Logo

Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim Biosimilar

Share this

Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim Biosimilar

Shots:

  • The US FDA has accepted the BLA for a proposed biosimilar to Neulasta (pegfilgrastim) by filing using the 351(k) pathway
  • The BLA submission is based on similarity data from analytical- PK- PD- and immunogenicity studies. The focus is to provide affordable solutions to reduce the disease burden
  • The US FDA filing is the first biosimilar filing of the company in the US. The biosimilar has estimated annual sales of $3.66B in the US

  Ref: Lupin | Image: The Indian Express

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions