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T-24: Evaluating the Approval Pathway of Biosimilars in the U.S. Market

Poster Presenter

      Basirat A Adeyemi

      • Global Regulatory Affairs Post-Doctoral Fellow
      • Rutgers, The State University of New Jersey
        United States


The objective of this study is to evaluate the approval pathway of Biosimilar products in the United States in comparison to their reference products.


The information utilized for this study was obtained from publicly available information. Sources used include FDA’s drug database; FDA drug approved products and guidance(s) pertinent to Biosimilars and Biologics.


Innovative Biologic products undergo the 351(a) pathway where clinical data is pivotal in gaining approval. Whereas, section 351(k) of the PHS Act allows Biosimilars to undertake a shorter drug developmental program relying on clinical studies conducted on the reference product. Differences in molecular attributes cannot be overcome with clinical studies. Therefore, analytical studies are critical in the development of Biosimilars. The stepwise approach to generate data in support of the demonstration of Biosimilarity comprises of analytical studies, animal studies, clinical pharmacokinetic/pharmacodynamics studies, clinical immunogenicity assessment and additional clinical studies which may/may not be needed. However, types of data and studies necessary for any given Biosimilar development program may vary. Once Biosimilarity requirements to a reference product is established, extrapolation of data allows sponsor to seek licensure of the proposed Biosimilar for one or more indications for which reference product is licensed.


In summary, Biosimilars are approved via an abbreviated licensure pathway where demonstration of Biosimilarity to the Biologics (reference product) is based on: analytical studies, nonclinical studies and clinical studies. While clinical data is paramount in Biologics development, there is more emphasis on analytical data in the development of a Biosimilar product. Co-author: Andro Shenouda, PharmD, MS