title: Considerations in the early development of biosimilar products.
abstract: The widespread use and patent expiration of many biologics have led to global interest in development of biosimilar products. Because the manufacture of biologics, including biosimilars, is a complex process involving living systems, the development of a biosimilar is more rigorous than the development of a generic small molecule drug. Several regulatory agencies have established or are proposing guidelines that recommend a stepwise process to ensure the efficacy and safety of a biosimilar are highly similar to the reference product. This article also explores the early clinical phase of biosimilar development, which is particularly important to resolving any uncertainties that might remain following in vitro and in vivo evaluations and to enable a selective and targeted approach to Phase III clinical efficacy and safety investigation.
authors.affiliation: Pharmacy Practice, University of New England College of Pharmacy, Portland, ME 04103, USA. Electronic address: eli@une.edu.
authors.forename: Edward C
authors.initials: EC
authors.lastname: Li
authors.affiliation: Clinical Pharmacology, Pfizer, Collegeville, PA 19426, USA.
authors.forename: Richat
authors.initials: R
authors.lastname: Abbas
authors.affiliation: Pfizer Emerging Markets/Established Products Medicines Development Group, Pfizer, New York, NY 10017, USA.
authors.forename: Ira A
authors.initials: IA
authors.lastname: Jacobs
authors.affiliation: Biotechnology Clinical Development, Pfizer, San Diego, CA 92121, USA.
authors.forename: Donghua
authors.initials: D
authors.lastname: Yin
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000592:standards; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D017277:Drug Approval / Q000331:legislation & jurisprudence; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards; D014944:World Health Organization
chemical_list: D059451:Biosimilar Pharmaceuticals