USFDA approves Biocon’s sBLA for Pegfilgrastim new manufacturing facility

Biocon has announced that Biocon and Mylan’s supplemental Biologics License Application (sBLA) for Pegfilgrastim drug substance to be manufactured at Biocon’s new Biologics manufacturing facility has been approved by the US Food and Drug Administration (FDA).

This additional approval of its new manufacturing facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics and Mylan to scale up capacity multi-fold and address the growing market opportunities in the US and other global markets. The US FDA had conducted a pre-approval inspection of this new drug substance manufacturing facility from 10^th September, 2019 to 19^th September, 2019.

Dr Christiane Hamacher, CEO, Biocon Biologics, said, “We are extremely pleased with the US FDA approval of our sBLA for Pegfilgrastim manufactured at our new Biologics drug substance facility. This is a significant milepost in our journey of serving five million patients by FY22 and crossing a revenue milestone of $1 billion. Biocon Biologics has been making continued investments in building global-scale, cost-competitive, complex manufacturing capabilities to address global market opportunities. This approval will help us better meet global patient needs for Fulphila, a high-quality biosimilar Pegfilgrastim co-developed with Mylan and manufactured by Biocon Biologics.

“Continued penetration of biosimilars will enable higher cost savings for the US healthcare system leading to expansion of patient access to high-quality affordable biologics. We are committed to use our science, scale and expertise to shift the access paradigm for patients in need of biosimilars like Pegfilgrastim across the globe,” she added.

Biocon Biologics, through its partner Mylan, has commercialized three of its co-developed biosimilars in developed markets like the US, 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. It was one of the most successful biosimilar launches in the US.

With the approval of this additional facility, Biocon Biologics 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 US, as well as in other global markets. Fulphila is also approved in other developed markets of EU, Australia and Canada.