Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim Biosimilar

 Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim Biosimilar

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

Click here to­ read full press release/ article | Ref: Lupin | Image: The Indian Express

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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