Taiwan’s Tanvex Welcomes US Filgrastim Approval – After String Of CRLs

Will Compete With Sandoz, Pfizer, Amneal Filgrastim Biosimilars

Tanvex Biopharma submitted an application for biosimilar filgrastim as far back as 2018. Now, after multiple setbacks, the firm has celebrated becoming a commercial-stage company in the US.

Form close up, fountain pen and approved stamped on a document. Soft focus.
• Source: Shutterstock

Taiwan’s Tanvex Biopharma has welcomed “moving beyond being a clinical/developmental stage company to a commercial company in the US,” after receiving US Food and Drug Administration approval for its Nypozi (filgrastim-txid) biosimilar to Amgen’s Neupogen.

Nypozi, formerly known as TX01, is the first biosimilar filgrastim product approved by the FDA since Amneal’s Releuko (filgrastim-ayow) in February 2022

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