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  1. FDA STEM Outreach, Education and Engagement

Comparison of pharmacokinetic methods across approved biosimilars

Authors:
Poster Author(s)
Palen, Trexy, FDA/CDER (Student); Wang, Yow-Ming, FDA/CDER (Mentor)
Center:
Contributing Office
Center for Drug Evaluation and Research

Abstract

Poster Abstract

Biosimilar drug is a biological product that is highly structurally similar to an FDA-licensed reference product, with no clinically meaningful difference in terms of product quality, safety and efficacy. The comparative pharmacokinetic (PK) profile of a biosimilar to reference product is required for approval of a biosimilar. Thus, a robust and validated PK bioanalytical method is crucial to support the PK profile analysis. However, PK methods can be different across biosimilars even if they have the same reference product. We compared 29 FDA-approved biosimilars that share a reference product with one or more other approved biosimilars. Analysis was performed for two or more biosimilars of Neupogen (n=2), Avastin (n=3), Enbrel (n=2), Rituxan (n=3), Neulasta (n=4), Remicade (n=4), Herceptin (n=5), and Humira (n=6). Initial results show diversity of bioanalytical approaches used among applications of the same reference product. The method comparison among them can be helpful to identify the common and unique critical reagents, assay platform, and interference. This study can ultimately help standardize PK method review for future applications of biosimilar drugs in the same class.

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