Mission Fulphila - Mylan-Biocon Biosimilar Neulasta Takes The Stage In US
The first FDA-approved Neulasta biosimilar is here, opening up material earnings opportunities for partners Mylan and Biocon and affirming the duo's ability to deliver on their complex but high-value pipeline.
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Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar
The latest drug development news and highlights from our US FDA Performance Tracker.
Biocon’s facility in Bangalore, India, has failed to pass muster with the US FDA, raising questions on whether this could result in a pushback of commercialization timelines for partner Mylan’s biosimilar pegfilgrastim in the US. The European regulator has also not cleared the Bangalore site.
Biocon is building on its alliance with Mylan and the partners are adding biosimilar programs for insulin glargine 300 units/mL and pertuzumab to their pipeline. But there's little clarity on the duo's ongoing program for biosimilar adalimumab in the backdrop of Mylan's recent deal with Fujifilm Kyowa Kirin Biologics for its product.