Biocon Biologics on Thursday said it has inked a settlement and licence agreement with drug firm Janssen to commercialise its biosimilar product to treat various ailments like psoriasis, Crohn's disease and ulcerative colitis, in the U.S.
The company's product -- Bmab 1200 -- is a proposed biosimilar to the reference drug Stelara which had sales of $7 billion in the U.S. last year.
The agreement licenses the company to launch in the U.S. in February 2025, once approved by the U.S. Food and Drug Administration, Biocon Biologics said in a statement.
The company is a subsidiary of Biocon Ltd.
Biocon Biologics and Janssen have finalised the settlement agreement to dismiss the pending Inter Partes Review before the Patent Trial and Appeal Board of the U.S. Patent and Trademarks Office, the company said.
"We are pleased that this allows the company to be amongst the first launch group to offer a reliable, high quality biosimilar option to patients and healthcare providers in the United States with our bUstekinumab, Bmab 1200," Biocon Biologics CEO & MD Shreehas Tambe stated.
This development enables Biocon Biologics to build further on its existing immunology franchise in the U.S., he added.
Stelara (Ustekinumab) is a monoclonal antibody medication approved for the treatment of psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
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