INSUBCONTINENT EXCLUSIVE:
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 | Photo: X@BioconBiologics2 min read Last Updated Aug 29 2024 | 10:47 AM IST
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 License 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 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.(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest
of the content is auto-generated from a syndicated feed.)First Published: Aug 29 2024 | 10:47 AMIST
