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).
FDA approves Kashiv Biosciences’ filgrastim biosimilar
Biosimilars/News | Posted 15/04/2022 0 Post your comment
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 .
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 .
LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View last week’s headline article: Biocomparables aprobados en México
Browse the news in the Latin American Forum!
LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de la semana pasada: Biocomparables aprobados en México
!Explore las noticias en el Foro Latinoamericano!
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.