Biocon-Mylan Prime Pegfilgrastim Market Expansion
US Approves Biocon’s sBLA for New Pegfilgrastim Facility
Biocon-Mylan’s sBLA approval for pegfilgrastim made at a new Indian site gets FDA go-ahead, facilitating a "multi-fold" scale up in capacity. But it will be interesting to watch how impactful this could be on market dynamics in the US, where more competition has arrived.
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Initial market signals from Sandoz’ US launch of its Ziextenzo pegfilgrastim biosimilar are promising, global Biopharmaceuticals head Pierre Bourdage told Generics Bulletin.
Mylan is preparing to launch a trastuzumab biosimilar in the US, while progress of developing bevacizumab and aflibercept biosimilars continues. Insulin aspart and glargine are also in Mylan’s pipeline.
The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.