Biocon Biologics has reached a significant milestone with the finalization of a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson. This paves the way for the commercialization of Bmab 1200, its proposed biosimilar to Stelara®, in the United States. Under the agreement, BBL gains the license to introduce Bmab 1200 to the US market in February 2025, pending FDA approval. The FDA has already accepted BBL’s Biologics License Application for Bmab 1200 under the 351(k) pathway. Additionally, the settlement involves the dismissal of the pending Inter Partes Review for US 10961307 before the Patent Trial and Appeal Board. CEO Shreehas Tambe expressed contentment with the agreement, highlighting the company's commitment to scientific innovation. He emphasized the opportunity to offer a reliable biosimilar option in the US market, further strengthening BBL's foothold in immunology. Matthew Erick, Chief Commercial Officer – Advanced Markets, reiterated the significance of this achievement in providing affordable, life-changing biosimilar medicines to patients with inflammatory diseases. Stelara® (Ustekinumab), the reference brand, amassed $7 billion in US sales in 2023, showcasing the potential impact of Bmab 1200's market entry.

Biocon Biologics has reached a significant milestone with the finalization of a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson.