Biocon Biologics secures US market entry date for Bmab 1200, a Proposed Biosimilar to Stelara
Stelara (Ustekinumab) is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated immune diseases and has been approved for the treatment of psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.;
Bengaluru: Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the Company has signed a settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in the United States of America.
The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA. The U.S. FDA has accepted the Company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon Biologics and Janssen have finalized the settlement agreement to dismiss the pending Inter Partes Review (IPR) for US 10961307 before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademarks Office.
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