Passage of the Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar products. The Food and Drug Administration approved ABP215 (MVASI, bevacizumab-awwb, Amgen) as a biosimilar to US-licensed Avastin (bevacizumab, Genentech) based on an extensive comparative analytical characterization, data obtained in a pharmacokinetic similarity study in healthy subjects, and a comparative clinical study in patients with non-small cell lung cancer. The totality of the evidence for biosimilarity supported extrapolation of the data to support licensure as a biosimilar for other approved indications of US-licensed Avastin, without the need of additional clinical studies.
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