BENGALURU, Nov 5: Biocon Ltd, an innovation-led global biopharmaceuticals company, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Biologics Drug Product facility in Bengaluru.
Biocon had undergone a surveillance cGMP inspection of this Drug Product facility in Bengaluru from August 22 to 30, 2019, according to a Biocon statement here on Tuesday.
Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are pleased to receive the EIR from the US FDA for our large Biologics Drug Product facility in Bengaluru, which is a strong building block for our US Dollar One billion revenue target. We have US FDA approvals for bPegfilgrastim and bTrastuzumab, and have been making a difference to cancer patients with bPegfilgrastim”.
The US FDA in October had also approved Biocon’s new Drug Product (DP) filling line for biosimilar Trastuzumab 150 mg vials at the Biologics facility in Bengaluru.
“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 USD one billion by FY22, driven by the near term commercialisation of Trastuzumab and Insulin Glargine in the US, continual growth in existing developed and emerging markets and launch of Insulin Aspart and Bevacizumab in various global markets,” he added.
Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and is developing many independently. The company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases.
To address volume growth on account of increased penetration of its products in developed and emerging markets and also to support new biosimilar pipeline development and launches, Biocon Biologics 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.
(UNI)
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