Biocon arm inks pact to launch biosimilar Bmab 1200 in multiple countries

The biopharmaceutical company said that its subsidiary, Biocon Biologics has secured market entry for its proposed biosimilar, Bmab 1200, which is designed to compete with Stelara, in Europe, the UK, Canada, and Japan.

In a regulatory filing, the company said that Biocon Biologics has has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, collectively known as Janssen.

This pact enables Biocon Biologics to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in Europe, the United Kingdom (UK), Canada, and Japan.

Under the terms of this settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in the above mentioned regions. Regulatory filings for Bmab 1200 are currently under review.

Stelara (Ustekinumab) is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated immune diseases and has been approved for the treatment of psoriasis, Crohns disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The reference brand, Stelara, had worldwide sales of $10.85 billion in 2023.

Shreehas Tambe, CEO & managing director, Biocon Biologics, said, This settlement agreement is testament to our proven track record of science and innovation and is another key milestone in our journey to bring our biosimilar Bmab 1200 (bUstekinumab) to global markets. Bmab 1200 will significantly strengthen our immunology franchise, enabling us to offer an affordable and effective treatment option for patients impacted by autoimmune diseases.

Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025, once approved by the U.S. FDA. The U.S. FDA has accepted the companys Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.

Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The companys conosldidated net profit surged to Rs 659.7 crore in Q1 FY25 as compared with Rs 101.4 crore in Q1 FY24. Revenue from operations increased marginally year on year to Rs 3,432.9 crore in during the quarter.

Shares of Biocon shed 0.81% to Rs 354 on the BSE.

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