The U.S. Food and Drug Administration (FDA) has accepted Accord BioPharma, Inc’s Biologics License Application (BLA) for DMB-3115, a proposed biosimilar to ustekinumab (Stelara, Johnson & Johnson).
Ustekinumab is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
The BLA submission for DMB-3115 is based on results from phase III multi-regional 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.
Joint development for DMB-3115 was initiated in 2013 by Dong-A Socio Holdings and Meiji Seika Pharma, with exclusive commercialization rights granted to Intas Pharmaceuticals through a partnership announced in 2021. As a global subsidiary of Intas Pharmaceuticals, Accord BioPharma will be responsible for U.S. commercialization.
In October of 2023, Accord BioPharma reached a settlement with Janssen Biotech Inc., a Johnson & Johnson company, under confidential terms that would allow Accord BioPharma to launch its proposed ustekinumab biosimilar no later than May 15, 2025, pending its approval by the U.S. FDA.
Accord BioPharma has submitted three separate Biologics License Applications to the FDA for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim. Accord BioPharma is planning to introduce several additional biosimilars to the U.S. market during the next five years.
“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,” says Chrys Kokino, U.S. president of Accord, in a news release.
Biosimilar Landscape Overview
So far, a total of 45 biosimilars have been approved in the US, and 37 have been launched. Of these, there are nine adalimumab biosimilars for plaque psoriasis and hidradenitis suppurativa, two for etanercept, three infliximab biosimilars and one for ustekinumab.
