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Looking for fingerprints: bioanalytical characterization of biosimilars Full Text
Pharmaceutical Technology, 06/29/2012
FDA released its long–awaited draft guidance documents on biosimilars. The three documents outline the agency's thinking on the processes and requirements necessary to obtain approval for a biologic that could be demonstrated to be highly similar to an already marketed product. Central to the approval pathway is the idea that rigorous bioanalytical characterization of a proposed biosimilar would be the first step in showing that it is highly similar to a reference product. According to the draft guidance, the more comprehensive and robust the comparative structural and functional characterization of the innovator and proposed biosimilar, the more useful such characterization would be in determining what additional nonclinical and clinical studies might be needed for approval.