FDA clears Mylan, Biocon's Fulphila as first biosimilar in US of Amgen's Neulasta

Mylan and Biocon announced Monday that the FDA has approved Fulphila (pegfilgrastim-jmdb) for the treatment of febrile neutropaenia, marking the first authorisation of a biosimilar version of Amgen's Neulasta (pegfilgrastim) in the US. FDA Commissioner Scott Gottlieb remarked "bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access."  

The drugmakers noted that the approval of Fulphila was supported by analytical, non-clinical and clinical data showing its similarity to Neulasta, with Mylan indicating that it aims to launch the therapy in the US in the coming weeks. 

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The FDA accepted Mylan's filing seeking approval of the biosimilar in February 2017, with the regulator previously rejecting the drugmaker's initial submission last October to await data for facility requalification activities after plant modifications.  

Amgen recorded $1 billion in US sales of Neulasta in the first quarter of this year.

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