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Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115

Friday, January 05, 2024

Accord BioPharma, the U.S. specialty arm of Intas Pharmaceuticals Ltd., has received the U.S. Food and Drug Administration's (FDA) acceptance for its Biologics License Application (BLA) for DMB-3115. This biosimilar is designed to emulate the success of STELARA®, a leading drug developed by Janssen Biotech, Inc., approved for various conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. In 2022, STELARA achieved substantial sales of $13.9 billion in the U.S., establishing itself as one of the top-selling biologics.

Chrys Kokino, U.S. president of Accord, expressed enthusiasm for improving treatment accessibility for autoimmune diseases, emphasizing the potential financial relief for patients and the healthcare system through more affordable options like biosimilars.

The collaborative efforts for DMB-3115 began in 2013 with Dong-A Socio Holdings and Meiji Seika Pharma, eventually leading to exclusive commercialization rights for Intas Pharmaceuticals in 2021. Accord BioPharma, as a global subsidiary, will handle the U.S. commercialization.

Binish Chudgar, vice chairman and managing director of Intas Pharmaceuticals, emphasized the commitment to enhancing global access to high-quality biosimilar drugs through partnerships with Dong-A Socio Holdings and Meiji Seika Pharma.

The BLA submission for DMB-3115 is grounded in phase III multi-regional clinical trials for plaque psoriasis patients. The primary endpoint, the rate of change in the Psoriasis Area and Severity Index (PASI), demonstrated a high degree of similarity between DMB-3115 and its reference product, ustekinumab, with no clinically meaningful differences in quality, safety, and efficacy.

In October 2023, Accord BioPharma and Janssen Biotech Inc. reached a settlement, allowing Accord BioPharma to potentially launch its ustekinumab biosimilar by May 15, 2025, contingent on FDA approval.

This BLA acceptance aligns with Accord BioPharma's anticipation of forthcoming regulatory milestones. The company has submitted three separate Biologics License Applications for biosimilars of trastuzumab, pegfilgrastim, and filgrastim. Accord BioPharma envisions introducing multiple biosimilars to the U.S. market over the next five years.

 

Source: prnewswire.com

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