The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.
The FDA has approved Dong-A ST’s ustekinumab-srlf (Imuldosa), a biosimilar to Stelara, for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, the company announced in a release.1
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“This FDA approval indicates global recognition of Dong-A ST’s research and development excellence and global competitiveness,” said Jae-Hong Park, MD, head of research and development at Dong-A ST, in the release.1 “We look forward to a successful launch of Imuldosa in the US, the world’s largest pharmaceutical market, as we continue to develop innovative medicines to further strengthen our global presence.”
About Opportuniti
Trial Name: Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (Opportuniti)
Clinicaltrials.gov Identifier: NCT04785326
Sponsor: Dong-A ST Co., Ltd.
Summary: This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
READ MORE: FDA Approval Marks Epysqli as Second Soliris Biosimilar
The FDA approval of the biosimilar comes one year after Accord BioPharma, a subsidiary of Intas Pharmaceuticals and DONG-A ST’s US partner, submitted a Biologics License Application to the agency in October 2023.2
The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.2 The primary endpoint was the change in the Psoriasis Area and Severity Index for skin symptoms. Clinical data showed that ustekinumab-srlf and its reference product, ustekinumab, were highly similar and had no clinically significant differences in quality, safety, or efficacy.
There are currently 4 FDA-approved biosimilars referencing Stelara, all of which are human monoclonal antibodies that target IL-12 and IL-23 to reduce inflammation.3 The addition of ustekinumab-srlf to the market could potentially lower patient costs by increasing access to more treatment options.
“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,” said Chrys Kokino, US president of Accord BioPharma, in a news release.2 “Our mission to go beyond the biology of medicine includes seeking to ease the financial burden for patients and the US healthcare system by providing medicines that may be more affordable, such as biosimilars.”
Ustekinumab-srlf is the second FDA-approved biosimilar for Dong-A ST following the approval of tedizolid phosphate (Sivextro) in 2014.1 According to the release, the company previously submitted a marketing authorization application to the European Medicines Agency for the drug, which was accepted in July 2023.1
READ MORE: Biosimilars Resource Center
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