Biocon Ltd and Mylan N.V collaboration received an approval for their biosimilar pegfilgrastim from the American regulator FDA (US Food and Drug Administration) to sell in the US market.
"Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection following myelosuppressive chemotherapy. Fulphila is the second FDA-approved biosimilar through the Mylan-Biocon collaboration, further demonstrating the companies' leadership and commitment to expanding patient access to critical biologic medicines," said Biocon in a press release.
The company also announced the news through its Twitter handle.
#Biocon and #Mylan’s second #biosimilar for #cancer #patients approved by the #USFDA. Fulphila™ (pegfilgrastim-jmdb), First Biosimilar to Neulasta® to be approved. Read More: https://t.co/AWirT6guxL #BioconForBiologics pic.twitter.com/pyankyrTQk— Biocon (@Bioconlimited) 5 June 2018
Biocon shares reacted to the news by rising as much as 6.4 percent in early morning trade today to a new record high of Rs 696.60.
Last year, the collaboration got FDA approval for their breast cancer drug Trastuzumab. Fulphila is expected to be launched in the coming weeks.
Biosimilars are highly similar to already approved and sold biological medical product. The brand Neulasta already sells pegfilgrastim in the US.