Biocon And Mylan Prime Pegfilgrastim Expansion
US FDA Approves Biocon’s sBLA for New Pegfilgrastim Facility
Biocon-Mylan’s sBLA for pegfilgrastim made at a new Indian site gets an 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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Mylan and Biocon have launched their Ogivri trastuzumab biosimilar in the US, marking the second biosimilar rival to Herceptin and leading a new wave of trastuzumab biosimilars expected to arrive in the US early next year.
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.