FDA Approves Ustekinumab (STELARA) Biosimilar for Chronic Inflammatory Diseases

The US Food and Drug Administration (FDA) has approved ustekinumab-srlf (IMULDOSA), a biosimilar to ustekinumab (STELARA), for chronic inflammatory conditions including psoriasis, psoriatic arthritis (PsA), Crohn’s disease, and ulcerative colitis.¹

The biosimilar, from Accord BioPharma, was approved based on clinical data from a comprehensive development program showing that its pharmacokinetics, efficacy, safety, and tolerability were similar to that of STELARA. IMULDOSA was further validated to adhere to the FDA’s current guidelines for biosimilar products.

The indication is highly potential for Accord, as STELARA’s multifaceted use across multiple chronic inflammatory diseases resulted in worldwide sales exceeding $10 billion in 2023. The company intends to launch their biosimilar in the first half of 2025.

"For Accord BioPharma, this is another step forward in our efforts to deliver affordable treatments and satisfy patient needs," Chrys Kokino, US president of Accord, said in a statement. "The approval of IMULDOSA, our second biosimilar, is evidence of our growing momentum in the industry and our leadership in supporting families with accessible options to address urgent and critical medical conditions."

Accord additionally announced the FDA approval of trastuzumab (Herceptin) biosimilar trastuzumab-strf (HERCESSI), for the treatment of HER2-overexpressing breast, gastric, or gastroesophageal junction adenocarcinoma just last month.² The company intends to introduce “several additional biosimilars” to the US market in the coming 5 years.¹

The pathway to reaching marketed indication was particularly longer for IMULDOSA; the biosimilar was initially developed as molecule DMB-3115 by Dong-A Socio Holdings and Meiji Seika Pharma in 2013, before being acquired by Intas Pharmaceuticals in 2021. It will now be commercialized in the US under the global subsidiary Accord.

"We're proud to add IMULDOSA to our US biosimilar portfolio, which represents an affordable treatment option for patients living with painful inflammatory conditions,” Binish Chudgar, vice chairman and managing director of Intas, said in a statement. “It is Accord BioPharma's goal to go beyond biology and continuously work to provide affordable world-class treatments to patients. As our presence in the biosimilar market continues to grow, so does our commitment to offering high quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need to thrive."

References

1. ^{Accord BioPharma. FDA Approves IMULDOSA® (ustekinumab-srlf), Accord BioPharma's Biosimilar to STELARA® (ustekinumab), for the Treatment of Chronic Inflammatory Conditions. Press release. PR Newswire. Published October 14, 2024. https://prnmedia.prnewswire.com/news-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions-302274563.html}
2. ^{Accord BioPharma. Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer. Press release. PR Newswire. Published September 18, 2024. https://www.prnewswire.com/news-releases/accord-biopharma-inc-announces-us-food--drug-administration-approval-of-420mg-strength-of-hercessi-trastuzumab-strf-a-biosimilar-to-herceptin-trastuzumab-for-the-treatment-of-several-forms-of-her2-overexpressing-cance-302251163.html}