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Amneal & Kashiv Receive the US FDA’s Approval for Fylnetra (biosimilar, pegfilgrastim)

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Amneal & Kashiv Receive the US FDA’s Approval for Fylnetra (biosimilar, pegfilgrastim)

Amneal & Kashiv Receive the US FDA’s Approval for Fylnetra (biosimilar, pegfilgrastim)

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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