Biocon and pharma firm Mylan said CHMP has a positive opinion recommending approval for their pegfilgrastim biosimilar, Fulphila.
New Delhi: Biotechnology major Biocon and pharma firm Mylan said European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for their pegfilgrastim biosimilar, Fulphila. Fulphila is a biosimilar to Amgen’s pegfilgrastim Neulasta, the companies said in a statement.
The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by November 2018, it added.
“CHMP’s decision to recommend approval of Biocon and Mylan’s biosimilar Pegfilgrastim brings us a step closer to offer this high quality, affordable biologic therapy for cancer patients in the EU, having launched this product in the US, earlier this year,” Biocon CEO & Joint MD Arun Chandavarkar said.
Fulphila is the first USFDA-approved biosimilar for Neulasta in the US, the statement said.
Commenting on the development, Mylan President Rajiv Malik said: “We are very proud to be a leader in bringing the first wave of biosimilars to the European market and driving greater access to more affordable treatment options for patients living with chronic and life-threatening illness such as cancer.”
Receiving CHMP positive opinion for pegfilgrastim biosimilar, Fulphila, is a key milestone in this journey, he added.
According to IQVIA, Neulasta had brand sales of more than USD 450 million in Europe for the 12 months ending June 30, 2018, the statement said.