Shots:

• Post FDA approval in H1’18- CHMP has recommended Fulphila based on its biosimilarity data assessing Fulphila vs Neulasta (Amgen’s biosimilar) in patients with Neutropenia and demonstrated non-inferiority data in terms of PK- PD- safety- efficacy and immunogenicity
• The CHMP recommendation will be reviewed by EU with its expected results in H2’18
• Fulphila (pegfilgrastim) is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) targeted for febrile neutropenia (FN)

Ref: Biocon | Image: Evaluate