The regulatory filings for Bmab 1200 in certain markets are currently under review. Credit: Corona Borealis Studio/Shutterstock.

Biocon Biologics has reached a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (collectively called Janssen) for the commercialisation of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara (Ustekinumab).

Biocon plans to commercialise the product in key markets such as Europe, the United Kingdom, Canada and Japan on receipt of regulatory approvals.

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The agreement resolves patent disputes between the parties and enables market entry for Biocon Biologics’ product in these regions.

The regulatory filings for Bmab 1200 are currently under review.

The development follows the company’s previous announcement of a settlement agreement in the US, which permits the launch of Bmab 1200 no later than 22 February 2025, pending approval from the US Food and Drug Administration (FDA).

The FDA has accepted the company’s biologics licence application for Bmab 1200 under the 351(k) pathway.

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Stelara is a monoclonal antibody indicated to treat various immune-mediated ailments by targeting interleukin IL-12/23.

It is approved for conditions such as psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

The reference brand, Stelara, reported global sales of $10.85bn in 2023.

Biocon Biologics CEO and managing director Shreehas Tambe stated: “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.”

In May 2024, Biocon entered an exclusive licence and supply agreement with Handok to commercialise synthetic Liraglutide in South Korea.