Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.
|Articles|April 28, 2015
FDA Releases Final Biosimilar Guidance
Author(s)BioPharm International Editors
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
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FDA released final guidance documents on biosimilar products on Apr. 28, 2015. The three documents are:
The documents address comments from various industry perspectives and, according to FDA, “are intended to provide predictability and to make clear the scientific and regulatory considerations for sponsors initiating biosimilar development programs.”
Source: FDA
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