Biocon Biologics had previously announced a settlement agreement in the US for the launch of Bmab 1200 no later than February 22, 2025, once approved by the US FDA | Photo: X@BioconBiologics
Biocon Biologics said on Thursday it has signed a pact with Janssen to launch a biosimilar drug for the treatment of autoimmune diseases in Europe, the United Kingdom, Canada and Japan.
The company, a subsidiary of Biocon Ltd, has signed a settlement and licensing agreement with Janssen Biotech Inc, Janssen Sciences Ireland and Johnson & Johnson. This agreement paves the way for commercialisation of its Bmab 1200, a proposed biosimilar to Stelara.
Under the terms of the settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the U.K., Canada and Japan, the company said in a statement.
Regulatory filings in these markets are currently under review, he added.
Biocon Biologics had previously announced a US settlement agreement for the launch of Bmab 1200 no later than February 22, 2025, once approved by the US FDA.
The US health regulator has accepted the company’s biologics license application (BLA) for Bmab 1200 for review.
“This settlement agreement is a testament to our proven track record in science and innovation and is another key milestone in our journey to bring our biosimilar Bmab 1200 (bUstekinumab) to global markets,” said Biocon Biologics CEO and MD Shreehas Tambe.
Bmab 1200 will significantly strengthen the company’s immunology franchise, enabling it to offer an affordable and effective treatment option for patients affected by autoimmune diseases, he added.
Stelara (Ustekinumab) has been approved for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Stelara had global sales of $10.85 billion in 2023.
Shares of Biocon were up 0.9 per cent and trading at Rs 360.10 apiece on the BSE.
(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
First published: August 29, 2024 | 10:47 am IS
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