FDA Accepts Accord’s BLA for Stelara Biosimilar

The FDA has accepted Accord BioPharma’s biologic license application for DMB-3115, a biosimilar that references Johnson & Johnson’s Stelara (ustekinumab). Stelara treats several autoimmune diseases including Crohn’s disease, ulcerative colitis, and plaque psoriasis, and psoriatic arthritis.

Accord BioPharma is the U.S. specialty division of Intas Pharmaceuticals, which has a partnership with Dong-A Socio Holdings and Meiji Seika Pharma to develop DMB-3115. Instas has commercialization rights for the biosimilar.

The BLA submission for DMB-3115 is based on results from phase 3 clinical trials in patients with plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that DMB-3115 and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of quality, safety and efficacy.

In October 2023, Accord BioPharma reached a settlement with Janssen Biotech a Johnson & Johnson company, under confidential terms that would allow Accord BioPharma to launch its proposed ustekinumab biosimilar no later than May 15, 2025.

A marketing application fo DMB-3115 is also being received by the European Medicine Agency. 

Related: FDA Approves First Interchangeable Stelara Biosimilar

In November 2023, the FDA approved the first interchangeable biosimilar that references Stelara. Amgen’s Wezlana (ustekinumab-auub) is approved to treat patients with multiple inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Wezlana is expected to launch no later than Jan. 1, 2025, after an agreement with J&J.

According to the FDA, the approval of Wezlana is based on a review of scientific evidence demonstrating that there are no clinically meaningful differences between the two products in terms of safety, purity and potency. This evidence included comparisons of the products on an analytical level using chemical and biological tests and biological assays that confirmed similarity in the structural and functional features.

Other expected Stelara biosimilars include:

• Alvotech and Teva’s AVT04, which is expected to launch no later Feb. 21, 2025. Last month, the FDA issued a complete response letter for AVT04 because of deficiencies in Alvotech’s Iceland, facility. The company plans to resubmit its application once these are addressed.
• Fresenius Kabi and Formycon plan to launch their biosimilar to Stelara, FYB202, no later than April 15, 2025.