Accord BioPharma has secured the US Food and Drug Administration (FDA) approval for Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar to Stelara (ustekinumab).
The FDA approved the biosimilar nearly a year after Accord BioPharma submitted a biologics licence application (BLA) in October 2023. The application was accepted by the regulator in January 2024.
Accord BioPharma is the US speciality division of Intas Pharmaceuticals. The company expects to commercially launch Imuldosa in H1 2025.
Stelara, which is produced by Janssen Biotech, is used to treat autoimmune diseases like plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The FDA approval for Imuldosa covers all indications for Stelara.
Intas Pharmaceuticals vice chairman and managing director Binish Chudgar said: “We’re proud to add Imuldosa to our US biosimilar portfolio, which represents an affordable treatment option for patients living with painful inflammatory conditions. 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.”
Imuldosa was co-developed initially by Dong-A Socio and Meiji Seika Pharma as DMB-3115 in 2013. In July 2020, the research and development (R&D) and commercialisation rights were transferred from Dong-A Socio to Dong-A ST for better project management.
In July 2021, a global licence agreement was signed with Intas Pharmaceuticals, which will commercialise the biosimilar through its subsidiaries, including Accord BioPharma in the US and Accord Healthcare in the European Union (EU), UK, and Canada.
Imuldosa is now the second FDA-approved product developed by Dong-A ST after Sivextro (tedizolid phosphate), which was approved in 2014.
The BLA for Imuldosa is based on the findings of Phase 3 multi-regional clinical trials in patients with plaque psoriasis. The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms.
Results showed that DMB-3115 is highly similar to its reference product, ustekinumab, with no clinically meaningful differences in quality, safety, or efficacy.
Dong-A ST R&D head Jae-Hong Park said: “This FDA approval indicates global recognition of Dong-A ST’s R&D excellence and global competitiveness.
“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.”
Accord Healthcare has also filed a marketing authorisation application for the Imuldosa to the European Medicines Agency (EMA) in June 2023, which was accepted in July 2023.
The company has submitted three BLAs to the FDA for biosimilars of trastuzumab, pegfilgrastim, and filgrastim. Furthermore, Accord BioPharma plans to introduce several more biosimilars to the US market over the next five years.
Last month, Fresenius Kabi and Formycon received FDA approval for Otulfi (ustekinumab-aauz), their ustekinumab biosimilar referencing Stelara.
