Bio-Thera Follows EU Bevacizumab Biosimilar Filing With FDA Goal Date
Biosimilar Now Accepted For Filing With Three Major Regulators
China’s Bio-Thera is continuing its journey to bring biosimilars to patients across the globe, with its BAT1706 biosimilar bevacizumab candidate accepted for filing by the US Food and Drug Administration.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Amgen enters 2021 with a five-strong global biosimilars portfolio, spearheaded by its market-leading bevacizumab and trastuzumab products in the US. Management explained the contrasting fates of the two oncology biosimilars as it published full-year financial results.
Viatris and partner Biocon have seen FDA action on their application for a bevacizumab biosimilar rival to Avastin delayed by the need for a facility inspection, the timing of which is uncertain due to coronavirus-related restrictions.