Biocon and its partner Mylan on November 27 said their supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance to be manufactured at Biocon's new Biologics manufacturing facility in Bengalury has got USFDA's nod.
This additional approval of its new manufacturing facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics, a subsidiary of Biocon Ltd, and Mylan to scale up capacity multi-fold and address the growing market opportunities in the US and other global markets, Biocon said in a statement.
The USFDA had conducted a Pre-Approval Inspection (PAI) of this new Drug Substance manufacturing facility from September 10 - 19, 2019.
Biocon Biologics has been investing in expanding its manufacturing capacity in line with its expectations of higher biosimilars penetration in developed and emerging markets.
"This is a significant milepost in our journey of serving 5 million patients by FY22 and crossing a revenue milestone of $1 billion," said Christiane Hamacher, CEO, Biocon Biologics.
Biocon through its partner Mylan, has commercialised three of its co-developed biosimilars in developed markets like U.S., Canada, EU and Australia.
Fulphila, a biosimilar Pegfilgrastim co-developed by Biocon and Mylan, was the first biosimilar Pegfilgrastim to be approved in the US and was commercially launched in July 2018.
Mylan in its latest third quarter earnings said the market for biosimilar Pegfilgrastim is going at a high single-digit and around 23 percent of the total for innovator's Neulasta market has been converted to biosimilars.
Pegfilgrastim is a biosimilar version of Amgen's Neulasta used to stimulate the level of neutrophils, a type of white blood cell that gets damaged in cancer patients undergoing chemotherapy.
With the approval of this additional facility, Biocon and Mylan will be able to address the growing needs of patients for biosimilar Pegfilgrastim in the US where introduction of the biosimilar has expanded the overall market, increasing access for patients in the U.S., as well as in other global markets.