Key considerations in the preclinical development of biosimilars.
Biosimilar development requires several steps: selection of an appropriate reference biologic, understanding the key molecular attributes of that reference biologic and development of a manufacturing process to match these attributes of the reference biologic product. The European Medicines Agency (EMA) and the FDA guidance documents state that, in lieu of conducting extensive preclinical and clinical studies typically required for approval of novel biologics, biosimilars must undergo a rigorous similarity evaluation. The aim of this article is to increase understanding of the preclinical development and evaluation process for biosimilars, as required by the regulatory agencies, that precedes the clinical testing of biosimilars in humans.
Global Cancer Research Institute, Inc. (GCRI) for Personalized Oncology, San Jose, CA 95124, USA. Electronic address: lbui@gcrioncology.com.
Lynne A
LA
Bui
Development Strategies Group in the PDM (Pharmacokinetics, Dynamics, and Metabolism) Department, Pfizer Inc, Groton, CT 06340, USA.
Susan
S
Hurst
Drug Safety Research and Development, Pfizer Inc, Groton, CT 06340, USA.
Gregory L
GL
Finch
Pfizer Inc, Andover, MA 01810, USA.
Beverly
B
Ingram
Pfizer Emerging Markets/Established Products Medicines Development Group, Pfizer Inc, New York, NY 10017, USA.
Ira A
IA
Jacobs
Global Technology Services - BioManufacturing Sciences Group, Pfizer Inc, Chesterfield, MO 63017, USA.
Carol F
CF
Kirchhoff
Pfizer Inc, Andover, MA 01810, USA.
Chee-Keng
CK
Ng
Drug Safety Research and Development, Pfizer Inc, Groton, CT 06340, USA.
Anne M
AM
Ryan
D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000592:standards; D003257:Consumer Product Safety; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D006801:Humans; D015394:Molecular Structure; D011786:Quality Control; D012307:Risk Factors; D013329:Structure-Activity Relationship; D013810:Therapeutic Equivalency
D059451:Biosimilar Pharmaceuticals