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

Will Compete With Sandoz, Pfizer, Amneal Filgrastim Biosimilars

 
• By Dean Rudge

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...

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