1,171 results match your criteria BioDrugs[Journal]


Correction to: Vestronidase Alfa: A Review in Mucopolysaccharidosis VII.

BioDrugs 2019 Apr 16. Epub 2019 Apr 16.

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

The article Vestronidase Alfa: A Review in Mucopolysaccharidosis VII, written by Emma H. McCafferty and Lesley J. Scott, was originally published Online First without open access. Read More

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http://dx.doi.org/10.1007/s40259-019-00353-6DOI Listing

Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab.

BioDrugs 2019 Apr 10. Epub 2019 Apr 10.

Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.

Background: ABP 980 has been developed as a biosimilar to Herceptin (trastuzumab). Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare ABP 980 to trastuzumab reference products sourced from the United States (US) and the European Union (EU).

Methods: Physicochemical property comparisons included the following: primary structure related to amino acid sequence and post-translational modifications, including glycans; higher-order structure; product-related substances and impurities, including size and charge variants; subvisible and submicron particles, and protein content. Read More

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http://dx.doi.org/10.1007/s40259-019-00350-9DOI Listing

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 1-Biosimilar and Originator Infliximab in the Hospital Setting.

BioDrugs 2019 Apr 3. Epub 2019 Apr 3.

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Background: Decentralisation of healthcare budgets and issuance of local guidelines means that the use of biosimilars can vary by region within a particular country, for example between the 21 counties of Sweden.

Objectives: This study aimed to analyse the county-level market dynamics of biosimilar and originator infliximab, which are hospital products, and to examine how local policy measures and practices, in addition to national policy, influenced market dynamics.

Methods: We first conducted a literature review on (biosimilar) policies in Sweden, then analysed market data provided by IQVIA™ on uptake of originator and biosimilar infliximab within the different counties (Q2 2012 to Q4 2017), including discounts from (tender) contracts. Read More

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http://dx.doi.org/10.1007/s40259-019-00345-6DOI Listing

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 2-Biosimilar and Originator Etanercept in the Outpatient Setting.

BioDrugs 2019 Apr 3. Epub 2019 Apr 3.

Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Background: Diverging approaches towards market entry and uptake of biosimilars, even within a country, leads to regional variation in biosimilar use. This is the case in Sweden, where the 21 county councils control the healthcare budget and offer regional guidance.

Objectives: This study aimed to analyse the market dynamics of originator and biosimilar etanercept (outpatient setting) in the different counties of Sweden, and examine the influence of local policy measures and practices, in addition to national policy. Read More

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http://dx.doi.org/10.1007/s40259-019-00346-5DOI Listing

Physicochemical and Biological Characterization of RTXM83, a New Rituximab Biosimilar.

BioDrugs 2019 Mar 29. Epub 2019 Mar 29.

mAbxience, Carlos Villate 5148, Munro, B1605AXL, Buenos Aires, Argentina.

Background: RTXM83 is a rituximab biosimilar with proven clinical safety and efficacy. It is the first rituximab biosimilar developed and approved in South America and is currently marketed in several Latin American, Middle Eastern and African countries.

Objective: The aim of this study was to present the physicochemical and biological characterization studies utilized to demonstrate the similarity between RTXM83 and its reference product. Read More

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http://dx.doi.org/10.1007/s40259-019-00349-2DOI Listing
March 2019
5 Reads

PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.

BioDrugs 2019 Apr;33(2):207-220

Pfizer Inc, San Diego, CA, USA.

Background: Three comparative clinical studies assessed the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and safety of PF-06881893 (filgrastim-aafi; Nivestym™), a filgrastim biosimilar, versus US-licensed reference product (filgrastim; US-Neupogen) in healthy volunteers (HVs).

Methods: Two separate open-label, crossover-design PK/PD studies were conducted: a single-dose study (n = 24) and a multiple-dose study (n = 60). In each study, HVs were randomized to Nivestym followed by US-Neupogen, or vice versa. Read More

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http://dx.doi.org/10.1007/s40259-019-00343-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439167PMC

PARP Inhibitors and the Evolving Landscape of Ovarian Cancer Management: A Review.

BioDrugs 2019 Mar 21. Epub 2019 Mar 21.

BC Cancer, 600 West 10th Avenue, Vancouver, BC, V5Z 4E6, Canada.

As a drug class, inhibitors of poly-(ADP-ribose) polymerase (PARP) have had their greatest impact on the treatment of women with epithelial ovarian cancers (EOC), in particular, those with the most common histological subtype, high-grade serous cancer, as it has high rates of homologous recombination (HR) deficiency. PARP inhibition exploits this cancer vulnerability by further disrupting DNA repair, thus leading to genomic catastrophe. Early clinical data demonstrated the effectiveness of PARP inhibition in women with recurrent EOC harbouring BRCA1/2 mutations and those with platinum-sensitive recurrences. Read More

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http://dx.doi.org/10.1007/s40259-019-00347-4DOI Listing
March 2019
1 Read

LA-EP2006: A Pegfilgrastim Biosimilar.

Authors:
Sheridan M Hoy

BioDrugs 2019 Apr;33(2):229-232

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

LA-EP2006 (Ziextenzo) is the fifth biosimilar of pegfilgrastim, a pegylated recombinant granulocyte colony-stimulating factor, to be approved in the EU. It is approved for use in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) to reduce the duration of neutropenia and the incidence of febrile neutropenia. LA-EP2006 matched reference pegfilgrastim in terms of physicochemical characteristics and functional properties, and the pharmacodynamic and pharmacokinetic similarity of the medicines has been shown in healthy volunteers. Read More

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http://dx.doi.org/10.1007/s40259-019-00348-3DOI Listing
April 2019
2 Reads

Comparative Stability Studies of Different Infliximab and Biosimilar CT-P13 Clinical Solutions by Combined Use of Physicochemical Analytical Techniques and Enzyme-Linked Immunosorbent Assay (ELISA).

BioDrugs 2019 Apr;33(2):193-205

Department of Analytical Chemistry, Sciences Faculty/Biomedical Research Institute ibs.Granada, University of Granada, Fuentenueva Avenue s/n, 18071, Granada, Spain.

Background: There are two products in which infliximab is the active pharmaceutical ingredient. These are Remicade (INF; reference product) and Remsima™/Inflectra™ (CT-P13; infliximab biosimilar). Remsima™/Inflectra™ are bioidentical products. Read More

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http://dx.doi.org/10.1007/s40259-019-00342-9DOI Listing

A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males.

BioDrugs 2019 Apr;33(2):173-181

Inje University and Inje University Busan Paik Hospital, Busan, Republic of Korea.

Background: CT-P16 is a candidate biosimilar of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor that is used in the treatment of a range of advanced solid cancers.

Objective: The objective of this study was to demonstrate the pharmacokinetic equivalence of CT-P16 and European Union (EU)-approved bevacizumab (EU-bevacizumab) and US-licensed bevacizumab (US-bevacizumab) reference products.

Methods: In this double-blind, parallel-group phase I trial (ClinicalTrials. Read More

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http://dx.doi.org/10.1007/s40259-019-00340-xDOI Listing
April 2019
1 Read

Vestronidase Alfa: A Review in Mucopolysaccharidosis VII.

BioDrugs 2019 Apr;33(2):233-240

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

Mucopolysaccharidosis VII is an extremely rare, autosomal recessive lysosomal storage disorder characterized by a deficiency of β-glucuronidase activity, resulting in partial degradation and accumulation of GAGs in numerous tissues throughout the body, with consequent cellular damage and organ dysfunction. Enzyme replacement therapy (ERT) with intravenous vestronidase alfa (Mepsevii™), a recombinant form of human β-glucuronidase, is the first disease-specific therapy approved for the treatment of mucopolysaccharidosis VII in pediatric and adult patients. In the pivotal, blind start, phase 3 trial, 24 weeks of vestronidase alfa therapy significantly reduced urinary GAG (uGAG) excretion in patients with mucopolysaccharidosis VII. Read More

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http://dx.doi.org/10.1007/s40259-019-00344-7DOI Listing

CDK4/6 Inhibitors Expand the Therapeutic Options in Breast Cancer: Palbociclib, Ribociclib and Abemaciclib.

BioDrugs 2019 Apr;33(2):125-135

Department of OB&GYN, Breast Center, University of Munich (LMU), Marchioninistrasse 15, 81377, Munich, Germany.

The majority of patients with metastatic breast cancer (MBC) have hormone receptor-positive HER2-negative disease. For this subgroup, endocrine therapy is the key therapeutic option. Recently, therapeutic options have been expanded by introduction of the inhibitors of cyclin-dependent kinases 4/6 (CDK4/6i). Read More

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http://dx.doi.org/10.1007/s40259-019-00337-6DOI Listing
April 2019
1 Read

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals.

BioDrugs 2019 Apr;33(2):183-191

Department of Pharmacology, Medical University of Gdańsk, Dębowa Str. 23, 80-204, Gdańsk, Poland.

Introduction: There has been a significant increase in the volume of biosimilar medicines recently due to the expiries of patent protections of biologic medicines. Biosimilars are considered new medicines, and their usage in therapy is often associated with uncertainty from the perspectives of physicians, pharmacists and patients.

Objectives: The purpose of this study was to identify hospital pharmacist opinions towards these new medicines and investigate their usage in practice. Read More

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http://dx.doi.org/10.1007/s40259-019-00341-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439166PMC

First-Line Treatment of Non-Small-Cell Lung Cancer (NSCLC) with Immune Checkpoint Inhibitors.

BioDrugs 2019 Apr;33(2):159-171

Service de Pneumologie, Centre Hospitalier Intercommunal Creteil, 40 avenue de Verdun, 94010, Creteil, France.

Treatment of advanced-stage or metastatic non-small-cell lung cancers (NSCLCs) without EGFR mutations or ALK rearrangements, which can now be treated with molecularly targeted therapies, had been based on cytotoxic chemotherapy for a long time. Immune checkpoint inhibitors (ICIs), notably antibodies directed against programmed cell-death protein-1 (PD-1) and its ligand (PD-L1) have transformed therapeutic standards in thoracic oncology. These ICIs are now the reference second-line treatment and numerous phase III trials have examined their efficacy in treatment-naïve patients. Read More

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http://link.springer.com/10.1007/s40259-019-00339-4
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http://dx.doi.org/10.1007/s40259-019-00339-4DOI Listing
April 2019
6 Reads

The Relationship between Exosomes and Cancer: Implications for Diagnostics and Therapeutics.

BioDrugs 2019 Apr;33(2):137-158

Cell Therapy Institute, Nova Southeastern University, 3301 College Avenue, Fort Lauderdale, FL, 33314, USA.

Exosomes are very small extracellular vesicles secreted by cells to local and distant tissues. These mini signal transporters elicit acute and chronic effects on recipient cells. Studies regarding exosomes and their relationship to disease, as well as healthy functions, are eliciting extraordinary excitement as data pours in from groups around the world. Read More

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http://dx.doi.org/10.1007/s40259-019-00338-5DOI Listing

In-Use Stability of the Rituximab Biosimilar CT-P10 (Truxima) Following Preparation for Intravenous Infusion and Storage.

BioDrugs 2019 Apr;33(2):221-228

Biotechnology Research Institute, R&D Division, CELLTRION, Inc., 20, Academy-ro 51 Beon-gil, Yeonsu-gu, Incheon, 22014, Republic of Korea.

Background: CT-P10 is the first biosimilar of the anti-CD20 monoclonal antibody, rituximab. CT-P10 is currently available in over 51 countries worldwide, where it is approved in the same indications as its reference product rituximab. In-use stability studies are conducted for biologics to determine how conditions (e. Read More

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http://dx.doi.org/10.1007/s40259-019-00336-7DOI Listing
April 2019
5 Reads
2.989 Impact Factor

Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial.

BioDrugs 2019 Feb;33(1):79-91

CELLTRION, Inc., Incheon, Republic of Korea.

Objective: The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks.

Methods: In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Read More

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http://dx.doi.org/10.1007/s40259-018-00331-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373391PMC
February 2019
3 Reads

FKB327: An Adalimumab Biosimilar.

BioDrugs 2019 Feb;33(1):113-116

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

FKB327 (Hulio) is a biosimilar of the reference monoclonal anti-TNFα antibody adalimumab, and is approved in the EU for use in the same indications as reference adalimumab. FKB327 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and pharmacokinetic equivalence was shown in healthy volunteers and patients with moderate-to-severe rheumatoid arthritis (RA) despite methotrexate therapy. FKB327 demonstrated equivalent clinical efficacy to that of reference adalimumab in patients with moderate-to-severe RA, and similar tolerability, safety and immunogenicity profiles. Read More

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http://dx.doi.org/10.1007/s40259-019-00335-8DOI Listing
February 2019
1 Read

Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar.

Authors:
Sheridan M Hoy

BioDrugs 2019 Feb;33(1):117-120

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

Pegfilgrastim-jmdb/MYL-1401H (FULPHILA™) [hereafter referred to as pegfilgrastim-jmdb] is a biosimilar of the reference pegylated recombinant granulocyte colony-stimulating factor pegfilgrastim. It is approved for use in patients receiving chemotherapy for malignancy to decrease the incidence of infection, as manifested by febrile neutropenia, in the USA and to reduce the duration of neutropenia and the incidence of febrile neutropenia in the EU. Pegfilgrastim-jmdb has similar physicochemical characteristics and functional properties to those of US- and EU-sourced reference pegfilgrastim, and the pharmacodynamic and pharmacokinetic similarity of the agents has also been demonstrated in healthy volunteers. Read More

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http://dx.doi.org/10.1007/s40259-019-00334-9DOI Listing
February 2019
2 Reads

Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases.

BioDrugs 2019 Feb;33(1):15-32

Faculty of Medicine and Health Technology, Tampere University, Arvo Ylpön katu 34, 33520, Tampere, Finland.

Cytokines, many of which signal through the JAK-STAT (Janus kinase-Signal Transducers and Activators of Transcription) pathway, play a central role in the pathogenesis of inflammatory and autoimmune diseases. Currently three JAK inhibitors have been approved for clinical use in USA and/or Europe: tofacitinib for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, baricitinib for rheumatoid arthritis, and ruxolitinib for myeloproliferative neoplasms. The clinical JAK inhibitors target multiple JAKs at high potency and current research has focused on more selective JAK inhibitors, almost a dozen of which currently are being evaluated in clinical trials. Read More

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http://link.springer.com/10.1007/s40259-019-00333-w
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http://dx.doi.org/10.1007/s40259-019-00333-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373396PMC
February 2019
5 Reads

Comment on "The End of Phase 3 Clinical Trials in Biosimilars Development?"

Authors:
Sarfaraz K Niazi

BioDrugs 2019 Feb;33(1):121-123

University of Illinois, Chicago, IL, USA.

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http://dx.doi.org/10.1007/s40259-018-0330-1DOI Listing
February 2019
1 Read

Monoclonal Antibodies for Multiple Sclerosis: An Update.

BioDrugs 2019 Feb;33(1):61-78

Department of Neurology, University Hospital, Medical Faculty Heinrich-Heine-University, Moorenstraße 5, 40225, Düsseldorf, Germany.

The use of monoclonal antibodies in multiple sclerosis (MS) patients is in a transitional period. Studies regarding well-established, effective antibodies such as natalizumab and alemtuzumab focus more and more on long-term efficacy and safety, risk management, and treating complications. Primary progressive MS, a disease that was long considered to be unmodifiable, is currently in focus following ocrelizumab being approved as the first drug with a proven beneficial effect on the disease course. Read More

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http://link.springer.com/10.1007/s40259-018-0327-9
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http://dx.doi.org/10.1007/s40259-018-0327-9DOI Listing
February 2019
17 Reads

Current Ebola Virus Vaccine Progress.

BioDrugs 2019 Feb;33(1):9-14

Galveston National Laboratory, and Department of Microbiology and Immunology, University of Texas Medical Branch, Galveston, TX, USA.

Over 40 years since the discovery of Ebola virus, the anti-Ebola virus vaccine efforts of the past 2 decades have culminated in over 12 different vaccine candidates that have been placed into a number of clinical trial phases, past and present. Of these 12 vaccines, four candidates are up to or in phase II clinical trials, and only one has completed the phase III clinical trial stage. While remarkable progress toward a national regulatory agency-approved vaccine for Ebola virus has been made, there remain unanswered questions on issues such as, but not limited to, vaccine protective immunity and duration of that immunity, and the appropriate vaccination strategy for those at risk of Ebola virus infection. Read More

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http://dx.doi.org/10.1007/s40259-018-0329-7DOI Listing
February 2019
7 Reads

The Impact of the Fecal Microbiome on Cancer Immunotherapy.

BioDrugs 2019 Feb;33(1):1-7

Department of Medicine, University of Chicago, 5841 S. Maryland Ave. MC2115, Chicago, IL, 60637, USA.

Recent advances in culture-free methods of studying the human microbiome, coupled with strong bioinformatics tools, have provided new insights on the role of the human microbiome in health and disease. The human gut, in particular, houses a vast number and diverse variety of microbes. A plethora of evidence has demonstrated the significant effects of the gut microbiome on local and systemic immunity. Read More

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http://dx.doi.org/10.1007/s40259-018-0328-8DOI Listing
February 2019
1 Read

Mechanisms and Management of Chimeric Antigen Receptor T-Cell Therapy-Related Toxicities.

BioDrugs 2019 Feb;33(1):45-60

Department of Blood and Marrow Transplantation and Cellular Immunotherapy, Moffitt Cancer Center, 12902 Magnolia Drive, FOB-3, Tampa, FL, 33612, USA.

Chimeric antigen receptor T-cell (CAR-T) therapy has proven to be a very effective cancer immunotherapy. Axicabtagene ciloleucel and tisagenlecleucel are the first-in-class anti-CD19 CAR-T currently available for relapsed/refractory adult large B-cell lymphoma. Tisagenlecleucel is also available for pediatric and young adult (up to age 25 years) patients with relapsed/refractory B-acute lymphoblastic leukemia. Read More

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http://link.springer.com/10.1007/s40259-018-0324-z
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http://dx.doi.org/10.1007/s40259-018-0324-zDOI Listing
February 2019
20 Reads

Lanadelumab for the Prophylactic Treatment of Hereditary Angioedema with C1 Inhibitor Deficiency: A Review of Preclinical and Phase I Studies.

BioDrugs 2019 Feb;33(1):33-43

Division of Rheumatology, Allergy and Immunology, University of California, San Diego, 8899 University Center Lane, Suite 230, San Diego, CA, 92122, USA.

Hereditary angioedema (HAE) with C1 esterase inhibitor (C1-INH) deficiency (C1-INH-HAE) is a rare disease characterized by diminished levels or dysfunctional activity of C1-INH, leading to dysregulated plasma kallikrein activity within the kallikrein-kinin pathway. Symptoms manifest as painful, potentially life-threatening swelling of subcutaneous tissues throughout the body and/or submucosal edema in the upper airway or gastrointestinal tract. Attacks recur with unpredictable frequency, intensity, and duration, placing a heavy burden on patients' daily lives. Read More

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http://dx.doi.org/10.1007/s40259-018-0325-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373397PMC
February 2019
2 Reads

Comparison of the Pharmacokinetic-Pharmacodynamic Relationships of Two Darbepoetin Alfa Formulations in Healthy Male Volunteers.

BioDrugs 2019 Feb;33(1):101-112

Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.

Objective: This study compared the pharmacokinetic (PK), pharmacodynamic (PD), and safety properties of the test (CJ-40001) and reference (NESP) versions of darbepoetin alfa following a single subcutaneous (SC) or intravenous (IV) administration in healthy male subjects.

Methods: A single-blind, randomized, single-dose, two-period, two-intervention crossover study was conducted, with two separate parts consisting of SC or IV administration. In each period, either a test or reference product was administered via the SC or IV route. Read More

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http://link.springer.com/10.1007/s40259-018-0323-0
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http://dx.doi.org/10.1007/s40259-018-0323-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373390PMC
February 2019
20 Reads

A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of Proposed Biosimilar GB242 and Reference Infliximab in Healthy Subjects.

BioDrugs 2019 Feb;33(1):93-100

Department of Pharmacy, Peking University People's Hospital, Beijing, China.

Objective: The objective of this study was to compare the pharmacokinetics (PKs), safety, and immunogenicity of GB242 as a potential biosimilar infliximab with those of reference infliximab in healthy Chinese subjects.

Methods: We conducted a randomized, single-center, double-blind, parallel-controlled phase I study in which 48 healthy subjects were divided equally into a GB242 group and reference infliximab group. Both the test and reference drug were administered as a single intravenous dose of 3 mg/kg. Read More

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http://dx.doi.org/10.1007/s40259-018-0326-xDOI Listing
February 2019
4 Reads
2.989 Impact Factor

Comparative Effectiveness and Safety of Monoclonal Antibodies (Bevacizumab, Cetuximab, and Panitumumab) in Combination with Chemotherapy for Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis.

BioDrugs 2018 Dec;32(6):585-606

Postgraduate Program in Medicines and Pharmaceutical Services, School of Pharmacy, Federal University of Minas Gerais, Belo Horizonte, Brazil.

Background: The last decade has seen the increasing use of biological medicines in combination with chemotherapy containing 5-fluorouracil/oxaliplatin or irinotecan for the treatment of metastatic colorectal cancer (mCRC). These combinations have resulted in increased progression-free survival (PFS) in patients with mCRC; however, there are remaining concerns over the extent of their effect on overall survival (OS). Published studies to date suggest no major differences between the three currently available monoclonal antibodies (MoAbs); however, there are differences in costs. Read More

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http://dx.doi.org/10.1007/s40259-018-0322-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6290722PMC
December 2018
3 Reads

Recombinant Antibody Production in CHO and NS0 Cells: Differences and Similarities.

BioDrugs 2018 Dec;32(6):571-584

Department of Chemical and Biomolecular Engineering, Johns Hopkins University, Baltimore, MD, 21218, USA.

The commercial production of monoclonal antibodies (mAbs) has revolutionized the treatment of many diseases, including cancer, multiple sclerosis, and rheumatoid arthritis. These biotherapeutics have the potential to generate a global annual revenue of more than US$150 billion. Two cell hosts are predominantly utilized to produce these mAbs: Chinese hamster ovary (CHO) cells and murine myeloma cells (NS0). Read More

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http://link.springer.com/10.1007/s40259-018-0319-9
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http://dx.doi.org/10.1007/s40259-018-0319-9DOI Listing
December 2018
19 Reads

Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What's the Difference?

BioDrugs 2018 Dec;32(6):531-546

Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.

Interleukin-6 (IL-6) signaling is a critical target in inflammatory pathways. Today, tocilizumab (TCZ) and sarilumab (SAR), two IL-6 receptor-inhibiting monoclonal antibodies, are widely used in the treatment of rheumatoid arthritis (RA), with a favorable efficacy/safety profile. Successful introduction of such agents in the treatment of RA has encouraged the development of other agents targeting different points of the pathway. Read More

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http://dx.doi.org/10.1007/s40259-018-0320-3DOI Listing
December 2018
6 Reads

GP2017: An Adalimumab Biosimilar.

Authors:
Young-A Heo

BioDrugs 2018 Dec;32(6):635-638

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

GP2017 (adalimumab) is a biosimilar anti-TNF-α antibody. It is approved in the EU for use in all indications for which reference adalimumab is approved. GP2017 has similar physicochemical and functional properties to those of reference adalimumab, and the pharmacokinetic similarity of the agent has been shown in healthy male volunteers. Read More

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http://dx.doi.org/10.1007/s40259-018-0318-xDOI Listing
December 2018
24 Reads

Correction to: PF-06438179/GP1111: An Infliximab Biosimilar.

BioDrugs 2018 12;32(6):643

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

The article PF-06438179/GP1111: An Infliximab Biosimilar, written by Zaina T. Al-Salama. Read More

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http://dx.doi.org/10.1007/s40259-018-0316-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6302982PMC
December 2018
1 Read

Bispecific Antibody Emicizumab for Haemophilia A: A Breakthrough for Patients with Inhibitors.

BioDrugs 2018 Dec;32(6):561-570

Hemophilia Comprehensive Care Centre, Charlotte Maxeke Johannesburg Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand and NHLS, 7 York Road, Parktown, Johannesburg, 2193, South Africa.

Current unmet needs in haemophilia A patients with inhibitors include the need for intravenous infusion of replacement therapy and the high burden of treatment associated with prophylaxis. Emicizumab is a humanised bispecific monoclonal antibody designed to address these unmet needs and has completed phase III clinical trials in adolescents/adults (HAVEN 1) and paediatric (HAVEN 2) inhibitor populations. In HAVEN 1, there was an 80% bleed reduction across all bleeds, 89% reduction in treated joint bleeds, 92% reduction in treated spontaneous bleeds, and 95% reduction in treated target joint bleeds on emicizumab compared with no prophylaxis. Read More

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http://dx.doi.org/10.1007/s40259-018-0315-0DOI Listing
December 2018
3 Reads

In-Use Physicochemical and Biological Stability of the Trastuzumab Biosimilar CT-P6 Upon Preparation for Intravenous Infusion.

BioDrugs 2018 Dec;32(6):619-625

R&D Division, Biotechnology Research Institute, Celltrion Inc., Incheon, Korea.

Background: CT-P6 is a biosimilar of trastuzumab, a monoclonal antibody targeting human epidermal growth factor 2 (HER2), that is used in the treatment of breast and gastric cancers.

Objective: The aim of this study was to evaluate the in-use physicochemical and biological stability of CT-P6 following preparation for intravenous (IV) infusion.

Methods: One batch of CT-P6 within the final month of its 48-month shelf life was used to simulate sub-optimal administration conditions. Read More

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http://link.springer.com/10.1007/s40259-018-0314-1
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http://dx.doi.org/10.1007/s40259-018-0314-1DOI Listing
December 2018
27 Reads

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study.

BioDrugs 2018 Dec;32(6):607-617

Campania Pharmacovigilance and Pharmacoepidemiology Regional Centre, Section of Pharmacology "L. Donatelli", Department of Experimental Medicine, University of Campania "L. Vanvitelli", Naples, Italy.

Background: In recent years, several biosimilar drugs, including those of infliximab, have obtained marketing authorization from the European Medicines Agency (EMA). Given the peculiarity of the safety profile of biological medical products (originator and biosimilars), the evaluation of their tolerability represents an important component of pre-marketing and post-marketing clinical development. For example, infliximab products may cause adverse drug reactions (ADRs) including acute infusion reactions, delayed hypersensitivity reactions, and loss of efficacy, as a direct consequence of immunogenicity. Read More

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http://link.springer.com/10.1007/s40259-018-0313-2
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http://dx.doi.org/10.1007/s40259-018-0313-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6290713PMC
December 2018
16 Reads

Emerging Technologies for Delivery of Biotherapeutics and Gene Therapy Across the Blood-Brain Barrier.

BioDrugs 2018 Dec;32(6):547-559

Human Health Therapeutics Research Centre, Translational Bioscience, National Research Council Canada, 1200 Montreal Road, Ottawa, ON, Canada.

Antibody, immuno- and gene therapies developed for neurological indications face a delivery challenge posed by various anatomical and physiological barriers within the central nervous system (CNS); most notably, the blood-brain barrier (BBB). Emerging delivery technologies for biotherapeutics have focused on trans-cellular pathways across the BBB utilizing receptor-mediated transcytosis (RMT). 'Traditionally' targeted RMT receptors, transferrin receptor (TfR) and insulin receptor (IR), are ubiquitously expressed and pose numerous translational challenges during development, including species differences and safety risks. Read More

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http://link.springer.com/10.1007/s40259-018-0309-y
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http://dx.doi.org/10.1007/s40259-018-0309-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6290705PMC
December 2018
6 Reads

Darvadstrocel: A Review in Treatment-Refractory Complex Perianal Fistulas in Crohn's Disease.

Authors:
Lesley J Scott

BioDrugs 2018 Dec;32(6):627-634

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

Darvadstrocel (Alofisel) consists of a suspension of expanded human allogeneic adipose-derived mesenchymal stem cells (eASCs). It is the first mesenchymal stem cell (MSC) advanced therapy approved in the EU for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to ≥ 1 conventional or biologic therapy. In the pivotal phase 3 ADMIRE-CD trial in this difficult-to-treat patient population, after standard-of-care fistula conditioning, add-on therapy with a single dose of darvadstrocel (120 million eASC) administered into the tissue surrounding complex perianal fistulas was significantly more effective than placebo (saline), with the darvadstrocel group having a higher combined remission rate (i. Read More

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http://dx.doi.org/10.1007/s40259-018-0311-4DOI Listing
December 2018
5 Reads

PF-06438179/GP1111: An Infliximab Biosimilar.

BioDrugs 2018 Dec;32(6):639-642

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

PF-06438179/GP1111 (Zessly; Ixifi) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; GP1111 is also approved in Japan. GP1111 has similar physicochemical characteristics and pharmacodynamic properties to those of reference infliximab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate-to-severe RA despite methotrexate therapy. GP1111 demonstrated clinical efficacy equivalent to that of reference infliximab in patients with moderate-to-severe RA, despite methotrexate therapy, and was generally well tolerated in this population. Read More

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http://link.springer.com/10.1007/s40259-018-0310-5
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http://dx.doi.org/10.1007/s40259-018-0310-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6290860PMC
December 2018
4 Reads

PF-05280014: A Trastuzumab Biosimilar.

Authors:
Julia Paik

BioDrugs 2018 Oct;32(5):515-518

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

PF-05280014 (Trazimera™) is the fourth biosimilar of the reference anti-HER2 antibody trastuzumab to be approved in the EU. It is approved for use in all indications for which reference trastuzumab is approved, including HER2-positive metastatic or early breast cancer and metastatic gastric cancer. PF-05280014 has similar physicochemical and pharmacodynamic properties to those of reference trastuzumab, and the pharmacokinetic similarity of the agents has been shown in women with metastatic or early HER2-positive breast cancer and healthy male volunteers. Read More

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http://link.springer.com/10.1007/s40259-018-0308-z
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http://dx.doi.org/10.1007/s40259-018-0308-zDOI Listing
October 2018
33 Reads

Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent.

BioDrugs 2018 Oct;32(5):397-404

Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands.

The nocebo effect is defined as the incitement or the worsening of symptoms induced by any negative attitude from non-pharmacological therapeutic intervention, sham, or active therapies. When a patient anticipates a negative effect associated with an intervention, medication or change in medication, they may then experience either an increase in this effect or experience it de novo. Although less is known about the nocebo effect compared with the placebo effect, widespread interest in the nocebo effect observed with statin therapy and a literature review highlighting the nocebo effect across at least ten different disease areas strongly suggests this is a common phenomenon. Read More

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http://link.springer.com/10.1007/s40259-018-0306-1
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http://dx.doi.org/10.1007/s40259-018-0306-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182448PMC
October 2018
2 Reads

ABP 980: A Trastuzumab Biosimilar.

Authors:
Sohita Dhillon

BioDrugs 2018 Oct;32(5):511-514

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

ABP 980 (KANJINTI™) is a biosimilar of the reference anti-HER2 antibody trastuzumab. In the EU, ABP 980 is approved for use in all indications for which reference trastuzumab is approved, including HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. ABP 980 has similar physicochemical and functional properties to those of reference trastuzumab, and the pharmacokinetic biosimilarity of the agents has been shown in healthy subjects. Read More

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http://dx.doi.org/10.1007/s40259-018-0305-2DOI Listing
October 2018
26 Reads

SB5: An Adalimumab Biosimilar.

Authors:
James E Frampton

BioDrugs 2018 Oct;32(5):507-510

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

SB5 (Imraldi) is a biosimilar of the reference anti-TNF monoclonal antibody adalimumab. It is approved for use in the following indications for which reference adalimumab is approved: rheumatoid arthritis (RA), juvenile idiopathic arthritis [polyarticular juvenile idiopathic arthritis (pJIA) and enthesitis-related arthritis (ERA)], axial spondyloarthritis [ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)], psoriatic arthritis (PsA), psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn's disease, pediatric Crohn's disease, ulcerative colitis (UC), and non-infectious uveitis. SB5 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and the pharmacokinetic similarity of these agents has been shown in healthy volunteers and patients with RA. Read More

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http://dx.doi.org/10.1007/s40259-018-0307-0DOI Listing
October 2018
5 Reads

Risk of Adverse Drug Events Observed with Baricitinib 2 mg Versus Baricitinib 4 mg Once Daily for the Treatment of Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BioDrugs 2018 Oct;32(5):415-423

Department of Internal Medicine Education, The First Affiliated Hospital, Guangxi Medical University, Nanning, 530021, Guangxi, China.

Background: On 23 April 2018, the Food and Drug Administration-based Advisory Committee approved the use of baricitinib 2 mg for the treatment of rheumatoid arthritis and suggested the possibility of serious adverse events associated with baricitinib 4 mg. Hence, we aimed to systematically compare the risk of adverse drug events observed with baricitinib 2 mg versus 4 mg for the treatment of patients with rheumatoid arthritis.

Methods: Electronic databases including the Cochrane library, MEDLINE, EMBASE and http://www. Read More

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http://link.springer.com/10.1007/s40259-018-0304-3
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http://dx.doi.org/10.1007/s40259-018-0304-3DOI Listing
October 2018
12 Reads

Small-Molecule Immune Checkpoint Inhibitors Targeting PD-1/PD-L1 and Other Emerging Checkpoint Pathways.

BioDrugs 2018 Oct;32(5):481-497

Aurigene Discovery Technologies Limited, Bangalore, India.

Advances in harnessing the immune system for cancer treatment have been spectacular in recent years as witnessed by the approval of a number of antibodies targeting the PD-1/PD-L1 immune checkpoint pathway spanning an expanding list of indications. However, it is well recognized that while these antibodies show impressive clinical activity, they suffer from shortcomings including the failure to show response in a majority of patients, their need to be administered by intravenous injection, and immune-related adverse events due to the breaking of immune self-tolerance. Small-molecule-based therapeutic approaches offer the potential to address the shortcomings of these antibody-based checkpoint inhibitors. Read More

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http://link.springer.com/10.1007/s40259-018-0303-4
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http://dx.doi.org/10.1007/s40259-018-0303-4DOI Listing
October 2018
46 Reads

Ensuring Product Quality, Consistency and Patient Supply over Time for a Large-Volume Biologic: Experience with Remicade.

BioDrugs 2018 Oct;32(5):405-414

Janssen Research & Development, LLC, Malvern, PA, USA.

Biologics are produced from living organisms in complex, multi-stage manufacturing processes and contain inherent variability, which must be understood and controlled during manufacturing to avoid unexpected changes in key quality attributes that may contribute to clinically meaningful differences. The process must also meet large commercial demand, while simultaneously being able to accommodate change without sacrificing product consistency. The four key components of successful biologics manufacturing are (1) a stable, well-defined proprietary cell line; (2) a good manufacturing practice (GMP)-compliant supply chain with a process control strategy defining acceptable levels of variability for target product/process attributes and capable of managing complex material flows; (3) a tightly controlled procedure for implementation of proposed process changes that ensures product consistency; and (4) built-in redundancy and flexibility providing the ability to adapt rapidly to unexpected developments. Read More

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http://link.springer.com/10.1007/s40259-018-0300-7
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http://dx.doi.org/10.1007/s40259-018-0300-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182491PMC
October 2018
15 Reads

Expanding the Boundaries of Biotherapeutics with Bispecific Antibodies.

BioDrugs 2018 Oct;32(5):441-464

Protein Chemistry Department, Genentech Inc., South San Francisco, CA, 94080, USA.

Bispecific antibodies have moved from being an academic curiosity with therapeutic promise to reality, with two molecules being currently commercialized (Hemlibra and Blincyto) and many more in clinical trials. The success of bispecific antibodies is mainly due to the continuously growing number of mechanisms of actions (MOA) they enable that are not accessible to monoclonal antibodies. One of the earliest MOA of bispecific antibodies and currently the one with the largest number of clinical trials is the redirecting of the cytotoxic activity of T-cells for oncology applications, now extending its use in infective diseases. Read More

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http://link.springer.com/10.1007/s40259-018-0299-9
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http://dx.doi.org/10.1007/s40259-018-0299-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182456PMC
October 2018
24 Reads

Pharmacokinetic and Immunological Considerations for Expanding the Therapeutic Window of Next-Generation Antibody-Drug Conjugates.

BioDrugs 2018 Oct;32(5):465-480

Department of Chemical Engineering, University of Michigan, 2800 Plymouth Rd, Ann Arbor, MI, 48109, USA.

Antibody-drug conjugate (ADC) development has evolved greatly over the last 3 decades, including the Food and Drug Administration (FDA) approval of several new drugs. However, translating ADCs from the design stage and preclinical promise to clinical success has been a major hurdle for the field, particularly for solid tumors. The challenge in clinical development can be attributed to the difficulty in connecting the design of these multifaceted agents with the impact on clinical efficacy, especially with the accelerated development of 'next-generation' ADCs containing a variety of innovative biophysical developments. Read More

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http://dx.doi.org/10.1007/s40259-018-0302-5DOI Listing
October 2018
5 Reads

Biosimilar Knowledge Among Oncology/Hematology Team Members in Colorado, USA: An Educational Initiative and Follow-Up Survey.

BioDrugs 2018 Oct;32(5):499-506

Complex Mechanisms of Disease, Aging and Trauma (CMDAT) Research Foundation, PO Box 460722, Denver, CO, 80246, USA.

Background: No data exist regarding oncology/hematology team members' knowledge of and views on biosimilars in Colorado, USA. Published research has suggested that health professionals may have a poor understanding of many issues related to biosimilars.

Objectives: Our goal was to increase oncology/hematology team members' knowledge of biosimilars and then use an anonymous online survey to assess the knowledge gained. Read More

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http://dx.doi.org/10.1007/s40259-018-0301-6DOI Listing
October 2018
3 Reads

Comment on "The End of Phase 3 Clinical Trials in Biosimilars Development?"

BioDrugs 2018 10;32(5):519-521

FDA Strategy and Regulatory Policy, Avalere Health Inc., Washington, DC, USA.

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http://dx.doi.org/10.1007/s40259-018-0297-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182457PMC
October 2018
4 Reads