US FDA Delays Approval of Biocon and Mylan’s Biosimilar for Trastuzumab

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European Union (EU) and the United States for these products.  In the EU, we posted that Biocon requested withdrawal and resubmission of its EMA applications for its trastuzumab and pegfilgrastim biosimilars as part of the procedural requirements linked to the re-inspection of Biocon’s facility.  In the US, Mylan and Biocon’s biosimilar was slated to be considered in early September.  However, the FDA recently notified Mylan that it will extend its target action date for their application of a biosimilar to trastuzumab until December 3, 2017.  A Biocon spokesperson stated that the order was to “review some of the clarificatory information submitted to [the regulator] as part of the application review process… [and that it] has no impact on the anticipated timeline for commercialization of this product in the U.S.”

Stay tuned to the Big Molecule Watch blog.