Biocon Biologics gets US market entry date for Bmab 1200, Stelara
Biocon Biologics has signed a settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson (known as Janssen that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in the US.
Under Review
The agreement licenses the company to launch in the United States, in February 2025, once approved by the US FDA. The US FDA has accepted the company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.
Agreement Settlement
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.
Words from Biocon
CEO: Biocon
Shreehas Tambe, CEO & managing director, Biocon Biologics Ltd, said: “This settlement agreement reflects our commitment and focus on science and innovation. We are pleased that this allows Biocon Biologics 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. This development enables Biocon Biologics to build further on our existing immunology franchise in the US. As a fully integrated biosimilars company, Biocon Biologics is committed to expanding access to life-changing treatments with our broad portfolio of products.”
CCO: Biocon
Matthew Erick, chief commercial officer – advanced markets, Biocon Biologics said: “This agreement for a biosimilar Ustekinumab is an important milestone in our company’s commitment to delivering affordable, life-changing biosimilar medicines.”
About 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.
