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Biocon Gains EU Manufacturing Certification for India Plants


Biocon said a subsidiary’s manufacturing centers in Bengaluru, India, were cleared by European Union authorities for biosimilar production.

Bangalore, India-based Biocon said its subsidiary Biocon Biologics India has received European Union Good Manufacturing Practice (GMP) certification for multiple biosimilars manufacturing facilities in Bengaluru, India.

The certificate of GMP compliance from the European Medicines Agency is for multiple biologics drug substance (DS) and drug product (DP) manufacturing facilities at Biocon Park in Bengaluru.

Biocon is a rising star among Indian biopharmaceutical companies, having successfully launched its products on international markets, a feat that required the company to meet higher standards for manufacturing quality and evidence than are generally required for domestic distribution.

Multiple Biosimilars to Roll off the Conveyor

The company said the Bengaluru facilities are used for the manufacture of DS and DP for bevacizumab, trastuzumab, pegfilgrastim biosimilars, as well as for packaging of insulin glargine for European Union markets. The inspections occurred in March 2020.

Biocon said the approval allows a “multifold” expansion of the company’s capacity to provide trastuzumab and pegfilgrastim for patients in the European markets. The trastuzumab biosimilar was commercialized in March 2019 and the commercialization of a pegfilgrastim product in the European Union is “imminent,” Biocon said in a statement.

“This certification would further enable the approval process of our biosimilar bevacizumab, the marketing authorization for which is currently under review by the European authorities,” Biocon said.

Christiane Hamacher, CEO and managing director of Biocon Biologics India, said the GMP certification would support the company’s designs to achieve a “milestone of $1 billion in revenues” by fiscal year 2022.

Two Biocon manufacturing facilities in Bengaluru received FDA approval in late 2019, allowing the start of commercial activities there.

The company has partnered with Mylan to commercialize 2 co-developed biosimilars, trastuzumab and insulin glargine, in the European Union.

In April, Biocon and Mylan launched a pegfilgrastim biosimilar, Fulphila, in Canada and Australia.

The first part of a 2-part story about the Indian biopharmaceutical industry and the regulatory limitations that affect its international marketing ambitions can be found here.

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