Amneal & Kashiv Receive the US FDA’s Approval for Fylnetra (biosimilar, pegfilgrastim)
- The US FDA has approved the BLA for pegfilgrastim, a biosimilar referencing Neulasta for neutropenia. The product has been developed in collaboration with Kashiv & will be available under the name Fylnetra
- The approval marks Amneal's third biosimilar approval for oncology-related products in 2022 & Kashiv’s second biosimilar approval in the same year. The companies also received approval for Releuko (filgrastim-ayow), a biosimilar referencing Neupogen & Alymsys (bevacizumab-maly), a biosimilar referencing Avastin
- Pegfilgrastim is expected to be available in H2’22 with a full patient support program. Kashiv plans to continue providing high-quality biosimilars to markets globally over the next few yrs.
Ref: Businesswire | Image: Kashiv
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