CHMP Recommends the Approval of Dong-A ST’s IMULDOSA, a Biosimilar to Stelara®

Dong-A ST (President/CEO Jae-Hun Jung, KRX:170900) announced on October 18^th that its biosimilar IMULDOSA^® (active ingredient: ustekinumab, development code DMB-3115), referencing Stelara^®, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

Accord Healthcare Limited (Accord), a subsidiary of Intas Pharmaceuticals and Dong-A ST’s partner, submitted the Marketing Authorisation Application (MAA) to the EMA in June 2023. On October 18^th (CET), the CHMP issued a recommendation for approval, further advancing DMB-3115’s journey toward the European Union.

The CHMP evaluates medicinal products based on scientific assessments of their quality, safety, and efficacy, providing guidance to the EMA. A positive CHMP recommendation is typically a key determinant in the European Commission’s (EC) marketing approval and after the CHMP Marketing Authorization Opinion, the EC decides whether to grant an official marketing authorization.

This achievement follows Dong-A ST’s success earlier this month, securing FDA approval for IMULDOSA^® on October 10, showcasing its R&D excellence to the world.

The biosimilar aims to treat-various immunology conditions, by offering an alternative to Stelara^®, originally developed by Janssen Biotech.

Stelara® is indicated for range of immunology indications and has recorded global sales of US$ 19 billion of which US$ 3.2 billion sales coming from Europe as per IQVIA MAT Jun’24 data.

IMULDOSA^® has been under joint development since 2013 by Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, Dong-A ST took over the R&D and commercialisation responsibilities to streamline global project management. A year later, the company signed a global licensing agreement with Intas Pharmaceuticals, paving the way for the biosimilar’s commercialisation through Accord BioPharma in the US and Accord Healthcare in the EU, UK, and Canada.

Dong-A ST stated that its R&D expertise has been reaffirmed by the positive CHMP opinion, following the FDA approval for IMULDOSA. The company also added that it is now focused on a successful launch of IMULDOSA in both the US and European markets, aiming to provide better treatment options for patients worldwide.

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