A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5102275 | PMC |
| http://dx.doi.org/10.1097/MJT.0000000000000391 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Persistence After Switching From Adalimumab Biosimilar MSB11022 to Adalimumab Biosimilar GP2017 in Patients With Chronic Inflammatory Rheumatic Diseases.
J Pharm Technol
December 2024
Rheumatology Department, Hospital de Sagunto, Port de Sagunt, Spain.
Provide real-world data on switching from adalimumab biosimilar MSB11022 to GP2017 related to persistence, adherence, and safety in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Retrospective cohort study that used registries and medical records from a single hospital (June 2022 to April 2024). Adult patients with RA, PsA, and axSpA treated with adalimumab biosimilar MSB11022 who switched to biosimilar GP2017 were identified and followed up until April 2024, or disenrollment.
View Article and Find Full Text PDFImpact of Nonmedical Switches From Reference Infliximab to Biosimilars on Disease Control Within a Rheumatology Practice.
J Pharm Technol
December 2024
Department of Medicine, Larner College of Medicine, The University of Vermont, Burlington, VT, USA.
Infliximab is an anti-tumor necrosis factor agent used to treat rheumatologic disease. Evidence on the safety of switching to biosimilars and the associated risk factors for flares/loss of disease control within rheumatology is limited. The primary objective is to evaluate nonmedical switches from reference infliximab to biosimilars in rheumatology on risks and level of disease control.
View Article and Find Full Text PDFCell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.
AAPS J
December 2024
Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.
View Article and Find Full Text PDFPharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 versus reference denosumab in healthy males: A randomized phase I study.
Clin Transl Sci
December 2024
Clinical Pharmacology Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Denosumab is a human IgG2 monoclonal antibody against receptor activator of nuclear factor kappa-B ligand (RANKL) for the treatment of osteoporosis and bone loss. HLX14 is a proposed biosimilar of denosumab. This randomized, parallel-group, two-part, phase I study aimed to compare the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 with reference denosumab in Chinese healthy adult male participants.
View Article and Find Full Text PDFConstruction and Expression of Fc-FGF21 by Different Expression Systems and Comparison of Their Similarity and Difference with Efruxifermin by In Vitro and In Vivo Studies.
Appl Biochem Biotechnol
December 2024
Academy of Pharmacy, Xi'an Jiaotong-Liverpool University, 111 Ren'ai Road, SD334F, Suzhou, 215123, Jiangsu, China.
Non-alcoholic steatohepatitis (NASH) is a potential serious disease, which almost has no available medicine for effective treatment today. Efruxifermin is a bivalent Fc-FGF21 candidate drug developed by Akero Therapeutics that has shown promising results in preclinical and clinical trials for NASH and may be approved in future. However, it is produced by Escherichia coli (E.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!