Biocon biologics facility gets FDA nod

India's biopharmaceutical giant has been investing in expanding manufacturing capacity in line with expectations of higher biosimilars penetration in developed and emerging market

Biocon campus as seen on company website

Biocon’s new biologics manufacturing facility in Bengaluru, India, has been approved by the FDA. Biocon and Mylan's supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance has also been approved for manufacture at the facility.

The US agency had conducted a Pre-Approval Inspection of this new Drug Substance manufacturing facility and this additional approval of the facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics, a subsidiary of Biocon, and Mylan to scale up capacity multi-fold and address the growing market opportunities in the US and other global markets.

Biocon Biologics is positioned as a fully integrated ‘pure play’ biosimilars organisation and 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 Dr Christiane Hamacher, CEO of Biocon Biologics. “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,” she added.

Biocon Biologics, through its partner Mylan, has commercialised three of its co-developed biosimilars in developed markets like 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.

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.

To learn more about building and maintaining these pharmaceutical facilities in India, attend the Cleanroom Technology Conference India in November 2020. The event is designed to highlight best practice and regulations affecting both cleanroom design and cleanroom operation across various sectors for those working in controlled environments and cleanrooms.

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