FDA Accepts Accord BioPharma's BLA for Proposed Ustekinumab Biosimilar DMB-3115

Accord BioPharma, Inc., the US specialty division of Intas Pharmaceuticals Ltd., has reached a significant milestone dermatology with the US Food and Drug Administration (FDA) accepting its Biologics License Application (BLA) for DMB-3115. This proposed biosimilar aims to replicate the success of ustekinumab (Stelara), developed by Janssen Biotech, Inc., and widely used for treating autoimmune disorders.

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Ustekinumab has been a game-changer in the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, with $13.9 billion in sales in 2022, making it one of the leading biologics. The acceptance of DMB-3115's BLA marks a crucial step toward providing patients with a more accessible avenue for the treatment of conditions associated with an overactive immune response.

Chrys Kokino, US president of Accord BioPharma, expressed enthusiasm, stating in a press release, "The ability of DMB-3115's reference product, STELARA, to treat autoimmune diseases is well established, and we're excited to take this important step toward providing patients a more accessible avenue to treatment for conditions that present such a significant disease burden."

Accord BioPharma is also addressing the financial burden for patients and the US health care system by providing more affordable options, such as biosimilars. The joint development of DMB-3115, initiated in 2013 by Dong-A Socio Holdings and Meiji Seika Pharma, with exclusive commercialization rights granted to Intas Pharmaceuticals in 2021, showcases a global commitment to advancing biosimilar accessibility.

Binish Chudgar, vice chairman and managing director of Intas Pharmaceuticals, highlighted the long-term commitment to improving global access to biosimilar drugs through partnerships. Accord BioPharma, as a global subsidiary, will be responsible for the U.S. commercialization of DMB-3115.

The BLA submission for DMB-3115 is rooted in phase III multi-regional clinical trials focusing on plaque psoriasis patients. The results demonstrated a high similarity between DMB-3115 and its reference product, ustekinumab, in terms of quality, safety, and efficacy, paving the way for potential approval by the FDA.

In October 2023, Accord BioPharma settled with Janssen Biotech Inc., allowing the proposed ustekinumab biosimilar to launch no later than May 15, 2025, pending FDA approval. The company has submitted BLAs for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim, signaling a strategic move towards introducing multiple biosimilars to the U.S. market in the next 5 years.

Reference

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115. News release. Accord BioPharma. January 4, 2024. Accessed January 4, 2024. https://prnmedia.prnewswire.com/news-releases/accord-biopharma-inc-announces-us-fda-acceptance-of-biologics-license-application-for-proposed-stelara-biosimilar-dmb-3115-302025983.html