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