Biocon settles with Janssen to commercialise biosimilar products in Europe, Canada, Japan

Biosimilar products: Biocon Biologics on Thursday said it has inked a pact with Janssen for launching a biosimilar medication for the treatment of autoimmune diseases in Europe, the United Kingdom, Canada, and Japan.

The company, a subsidiary of Biocon Ltd, has inked a settlement and licence agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson. This agreement clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara.

As per the terms of the settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan, the company said in a statement.

Regulatory filings in these markets are currently under review, it added.

Biocon Biologics had earlier announced a settlement agreement in the US for Bmab 1200 launch no later than February 22, 2025, once approved by the USFDA.

The US health regulator has accepted the company's Biologics Licence Application (BLA) for Bmab 1200 for review.

"This settlement agreement is the 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," Biocon Biologics CEO & Managing Director Shreehas Tambe said.

Bmab 1200 will significantly strengthen the company's immunology franchise, enabling it to offer an affordable and effective treatment option for patients impacted by autoimmune diseases, he added.

Stelara (Ustekinumab) has been approved for the treatment of psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis, biologics and psoriatic arthritis.

Stelara had worldwide sales of $10.85 billion in 2023.

Shares of Biocon were trading 0.9 per cent up at Rs 360.10 apiece on the BSE.