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Mission Fulphila - Mylan-Biocon Biosimilar Neulasta Takes The Stage In US

 
• By Anju Ghangurde

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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Mylan-Biocon's Biosimilar Neulasta Approval Opens Up Opportunities For The Partners

The Mylan NV-Biocon Ltd. partnership has delivered its second FDA-approved biosimilar, with the agency greenlighting Fulphila (pegfilgrastim-jmdb), the first biosimilar to Amgen Inc.’s Neulasta from the duo. Their biosimilar version of Roche’s breast cancer drug Herceptin (trastuzumab) was approved by the FDA in December 2017.

Fulphila’s approval is significant given the complete response letter (CRL)-ridden journey of biosimilar pegfilgrastims in general (including for the Mylan-Biocon version). It is expected to provide a material profit opportunity for the partners

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