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Biosimilars: Rationale and current regulatory landscape

Seminars in Arthritis and Rheumatism: Volume 45, Issue 5, Supplement, April 2016, Pages S1-S10



To discuss current terminology and the regulatory standards and processes involved in the development of biosimilars.


An Internet-based literature search through April 2015 was performed for information related to biosimilars in chronic inflammatory disorders. Keywords were as follows: biosimilar, development, manufacturing, characterization, structural, functional, preclinical, clinical, immunogenicity, rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn׳s disease, ulcerative colitis, and ankylosing spondylitis. The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) websites were searched for guidelines and information related to biosimilars.


Biosimilars are products that are highly similar to the reference product regarding quality, biological activity, safety, and efficacy. Biosimilars are biological products and not generic drugs and, thus, do not follow the same regulatory pathways as generic molecules. Rigorous early-stage structural, functional, and analytical testing, followed by nonclinical and clinical analyses comparing a biosimilar with its reference product, are required to demonstrate biosimilarity in regulatory markets worldwide.


The addition of biosimilars to the market has the potential to improve access to biologic therapies. Many regulatory agencies have enacted stringent pathways, which must be followed for a biosimilar to be labeled and approved as such; following the pathways will help protect and maintain the integrity, quality, and safety of the biosimilar product.

Keywords: Biosimilar, Biologic, Innovator, Reference product, Chronic inflammatory diseases, Nomenclature, Biosimilarity, Regulatory guidance, Regulatory pathways, Generics, Small-molecule drugs, Development.


Department of Internal Medicine, University of Nevada School of Medicine, 1707 W Charleston Boulevard, Suite 220, Las Vegas, NV 89102

This supplement was funded by Pfizer Inc. Ewa Olech, MD, was a paid consultant to Pfizer Inc for the research and/or authorship of this supplement. Medical writing and editorial support to prepare this supplement was provided by Guidemark Health and funded by Pfizer Inc. Ewa Olech has the following additional conflicts of interest to disclose: consultant: AbbVie Inc., Amgen Inc., Celgene Corporation, Genentech Inc., Janssen Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc., Sanofi-Aventis U.S. LLC, and UCB Inc.; research grants: AbbVie Inc., Amgen Inc., Genentech Inc., UCB Inc., and Vertex Pharmaceuticals Incorporated.