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Biocon Biologics Clinches US Market Launch Date for Bmab 1200, a Proposed Stelara® Biosimilar

NextEdge Admin

02 Mar 2024

2 min 52 sec

Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced the signing of a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson, collectively known as Janssen. This agreement paves the way for the commercialization of Bmab 1200, a proposed biosimilar to Stelara®, in the United States.

The agreement grants Biocon Biologics the license to launch Bmab 1200 in the United States in February 2025, pending approval by the U.S. FDA. The FDA has accepted the Biologics License Application (BLA) for Bmab 1200 for review under the 351(k) pathway.

As part of the settlement, Biocon Biologics and Janssen have resolved 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.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, expressed satisfaction with the settlement, highlighting the company’s commitment to science and innovation. The agreement positions Biocon Biologics to be among the first to offer a reliable biosimilar option in the U.S., expanding its immunology franchise in the country.

Matthew Erick, Chief Commercial Officer – Advanced Markets at Biocon Biologics, emphasized the importance of this biosimilar agreement in delivering affordable, life-changing medicines, further supporting patients impacted by inflammatory diseases.

Stelara® (Ustekinumab), the reference brand, achieved $7 billion in sales in the U.S. in 2023. Biocon Biologics, with its global biosimilars business, aims to enhance affordable access to high-quality biosimilars across various therapeutic areas.

Biocon Limited, the parent company, is an innovation-led global biopharmaceuticals company committed to providing affordable access to therapies for chronic conditions. The company has a diverse portfolio, including novel biologics, biosimilars, and complex small molecule APIs, with a focus on enhancing healthcare outcomes.