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
The post Lupin Reports the US FDA Acceptance of BLA for Pegfilgrastim Biosimilar first appeared on PharmaShots.
