title: Biosimilars: A Multidisciplinary Perspective.
abstract: A biosimilar is an officially regulated and approved copy of an originator biologic therapy. Improved affordability and consequent wider patient access compared with biologics are a significant appeal of biosimilars. Regulatory guidelines for biosimilar development and approval are rigorous and undergoing constant refinement. The process of licensing approval for all biosimilars requires demonstration of comparability in quality, efficacy, and safety between the biosimilar and reference (originator) product, which is undertaken in a stepwise procedure of nonclinical and clinical evaluation. The approval of >20 biosimilars in Europe in several drug classes, including the first monoclonal antibody biosimilar, bears testimony to the increasing regulatory acceptance of these agents. In contrast, the clinical application of biosimilars remains underrecognized by physicians across therapy areas. Therefore, this article aims to provide a comprehensive review of the biosimilar development process and to provide multidisciplinary guidance on the potential therapeutic utility of biosimilars in clinical practice. Specifically, experts discuss clinical developments in the introduction of biosimilars across the disciplines of gastroenterology, nephrology, oncology, and rheumatology, and from a payer perspective, and also highlight a common need for ongoing pharmacovigilance, robust head-to-head clinical studies, and real-world data to establish the long-term risk-benefit profile of biosimilars. In conclusion, significant potential exists for biosimilars to revolutionize biologic therapy by widening patient access across therapy areas.
authors.affiliation: Clinical Professor of Medicine (Rheumatology), Memorial University of Newfoundland, Canada. Electronic address: mkhraishi@gmail.com.
authors.forename: Majed
authors.initials: M
authors.lastname: Khraishi
authors.affiliation: Recently retired Medicines Procurement Specialist Pharmacist NHS South West and past Chairman of Pharmaceutical Market Support Group.
authors.forename: David
authors.initials: D
authors.lastname: Stead
authors.affiliation: IBD Clinical and Research Center, And 1st Medical Faculty, Charles University, Prague, Czech Republic.
authors.forename: Milan
authors.initials: M
authors.lastname: Lukas
authors.affiliation: Medical Oncology and Supportive Care in Cancer Unit Georges Pompidou European Hospital, Paris, France.
authors.forename: Florian
authors.initials: F
authors.lastname: Scotte
authors.affiliation: Clinic and Policlinic IV, Section of Nephrology, Munich University Hospital, Campus Innenstadt, Munich, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Schmid
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D005060:Europe; D006801:Humans; D060735:Pharmacovigilance; D018570:Risk Assessment
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals
keywords: Inflammatory Bowl Disease (IBD); Nephrology; arthritis; biosimilars; pharmacovigilance; safety