FDA approves Kashiv Biosciences’ filgrastim biosimilar

Biosimilars/News | Posted 15/04/2022 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has approved a filgrastim biosimilar produced by India-based Kashiv Biosciences. The biosimilar will be marketed under the trade name Releuko (filgrastim-ayow).

Filgrastim V14K20

In March 2022, it was announced that FDA had approved Kashiv Bioscience (Kashiv)’s filgrastim biosimilar, Releuko.

Filgrastim is a recombinant form of granulocyte colony-stimulating factor (G-CSF) which stimulates the production of neutrophils. It is used to treat low neutrophil count (neutropenia), which can occur in HIV/AIDS and following chemotherapy, and is sold under the brand name Neupogen by originator company Amgen.

Kashiv’s Releuko (filgrastim-ayow) biosimilar has been co-developed with US firm Amneal Pharmaceuticals and is expected to launch in the third quarter of 2022.

Kashiv CEO Chandramauli Rawal said the company is also developing a biosimilar to Amgen’s Neulasta (pegfilgrastim), aiming for FDA approval later in 2022. Pegfilgrastim is a PEGylated form of filgrastim with a longer half-life (15‒80 hours, compared to 3–4 hours). The company will face competition though, as FDA accepted an application for Lupin’s pegfilgrastim biosimilar back in June 2021 [1].

Kashiv and Amneal say they also hope to secure approval for a biosimilar to Avastin (bevacizumab), a monoclonal antibody treatment for several cancers. The originator product is sold by Genentech and was first approved in the US in 2004. South Korean company Celltrion is also developing a bevacizumab biosimilar and seeking approval in the US, as well as Europe and South Korea [2].

Related articles
Lupin forms partnership to market pegfilgrastim biosimilar in Brazil

FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA

Biosimilars of filgrastim


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1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Lupin’s pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 15]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-lupin-s-pegfilgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 15]. Available from: www.gabionline.net/biosimilars/news/celltrion-seeks-approval-for-bevacizumab-biosimilar-in-europe-us-and-korea

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