Biocon Biologics secures license agreement for biosimilar launch in US

In a landmark announcement, Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd, revealed its settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson. This agreement signifies a crucial step forward, granting Biocon Biologics the license to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in the United States starting February 2025, pending U.S. FDA approval.

The U.S. Food and Drug Administration (FDA) has officially accepted Biocon Biologics’ Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review, a process that operates under the 351(k) pathway. This review is a critical phase in making the biosimilar available in the U.S. market, where Stelara® has been a leading treatment option for various immune diseases, with sales hitting $7 billion in 2023.

The agreement also includes the dismissal of the pending Inter Partes Review (IPR) for US patent 10961307 before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office, marking the end of a significant legal hurdle for Biocon Biologics. This settlement underscores the collaborative spirit within the biopharmaceutical industry, aiming to enhance patient access to vital treatments.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd, emphasized the importance of this agreement, stating, “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 is a testament to Biocon Biologics’ dedication to expanding its immunology franchise in the U.S. and its broader commitment to making life-changing treatments more accessible. Matthew Erick, Chief Commercial Officer – Advanced Markets at Biocon Biologics, highlighted the agreement’s significance in supporting patients with inflammatory diseases and its role in driving positive changes within the healthcare industry.

Stelara (Ustekinumab), the reference brand, is a monoclonal antibody medication crucial for treating psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis by targeting the abnormal regulation of interleukin IL-12/23. Biocon Biologics’ entry into this market segment with Bmab 1200 represents a significant advancement in the availability of biosimilar options, offering potential cost savings and increased access for patients.

The agreement between Biocon Biologics and Janssen Biotech Inc. sets a noteworthy precedent in the biosimilars landscape, promising enhanced access to essential medications for patients in the United States. By joining the ranks of companies aiming to introduce biosimilar alternatives in the U.S. market, Biocon Biologics is not only contributing to healthcare affordability but also reinforcing the importance of collaboration and innovation in the pharmaceutical industry.

This initiative could significantly impact the biologics and healthcare sectors by providing more treatment options, potentially lowering healthcare costs, and improving patient outcomes in the realm of immune-mediated diseases. As Biocon Biologics prepares for the 2025 launch of Bmab 1200, the healthcare community eagerly anticipates the positive changes this will bring to the biosimilars market and patient care.