Biocon's Biologics drug products facility gets nod from US FDA

Biopharmaceuticals major Biocon Ltd said on Tuesday it has received an establishment inspection report from the US Food and Drug Administration (FDA) for its biologics drug product facility here, reaffirming its global scale manufacturing capability for high quality, affordable biosimilars for the US market.

Biocon had undergone the current good manufacturing practice inspection from August 22 to 30. The receipt of establishment inspection report indicates a successful closure of this inspection.

"Biocon is committed to the highest standards of quality and compliance," said CEO of Biocon Biologics Christiane Hamacher. "We are pleased to receive the establishment inspection report from the US FDA for our large biologics drug product facility in Bengaluru, which is a strong building block for our one billion dollar revenue target."

The company said it is uniquely positioned as a fully integrated pure-play biosimilars organisation in the world, committed to enabling affordable access to patients across the globe.

"We are targeting to serve the needs of over 2.5 million patients in FY20. We aspire to serve nearly five million patients and cross revenues of one billion dollars by FY22, driven by the near-term commercialisation of Trastuzumab and Insulin Glargine in the United States, continual growth in existing developed and emerging markets and launch of Insulin Aspart and Bevacizumab in various global markets."

Biocon Biologics said in a statement that it is investing in expanding its manufacturing capacities in line with its approach of modular expansion. The company has also been undertaking strategic partnerships and acquisitions to rapidly expand its biosimilars portfolio and increase the addressable market opportunity.

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