Objective: To review the scientific and regulatory aspects of biosimilar development and practical considerations for the use of biosimilars that are relevant to pharmacists.
Data sources: Literature searches of PubMed and congress abstracts for publications pertaining to biosimilars were conducted from January 2016 to January 2017. Individual drug company web pages and governmental, regulatory, and other agency websites were also reviewed.
Study selection/data extraction: Published articles, regulatory guidelines, and other sources covering biologic/biosimilar development and approval, reporting results of biosimilar studies or survey research, and/or identifying biosimilars in development or approved for use in Europe or the United States were reviewed and included.
Data synthesis: Biologic therapies have revolutionized the treatment of serious diseases, including hematological or autoimmune disorders and cancers. A biosimilar is highly similar to a licensed biologic (ie, reference or originator) and has no clinically meaningful differences in safety, purity, and potency. Unlike small-molecule drugs, biologics are large, complex proteins that cannot be exactly replicated, so the concept of a generic equivalent cannot be applied to biologics. Regulatory agencies have provided a framework for biosimilar approval, but there are many practical considerations for pharmacists, including interchangeability, substitution, naming, indication extrapolation, product labeling, therapeutic drug monitoring, manufacturer attributes, logistics of product use, and reimbursement.
Conclusions: Pharmacists will play a key role in managing the introduction of biosimilars into health care systems. Understanding the principles of biosimilar development and evolving regulatory guidelines relevant to their use will allow pharmacists to make informed decisions regarding formulary inclusion and educate patients and other health care providers about biosimilars.
Keywords: biotechnology; clinical practice; formulary; legal/regulatory issues; postmarketing surveillance.