- IMULDOSA obtained an approval suggestion from CHMP, who usually units the course of an EU advertising authorisation
SEOUL, South Korea–(BUSINESS WIRE)–Dong-A ST (President/CEO Jae-Hun Jung, KRX:170900) introduced on October 18th that its biosimilar IMULDOSA ® (lively ingredient: ustekinumab, growth code DMB-3115), referencing Stelara ®, has acquired a constructive opinion from the Committee for Medicinal Merchandise for Human Use (CHMP) below the European Medicines Company (EMA).
Accord Healthcare Restricted (Accord), a subsidiary of Intas Prescribed drugs and Dong-A ST’s associate, submitted the Advertising Authorisation Software (MAA) to the EMA in June 2023. On October 18th (CET), the CHMP issued a suggestion for approval, additional advancing DMB-3115’s journey towards the European Union.
The CHMP evaluates medicinal merchandise based mostly on scientific assessments of their high quality, security, and efficacy, offering steering to the EMA. A constructive CHMP suggestion is often a key determinant within the European Fee’s (EC) advertising approval and after the CHMP Advertising Authorization Opinion, the EC decides whether or not to grant an official advertising 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 goals to treat-various immunology circumstances, by providing a substitute for Stelara ®, initially developed by Janssen Biotech.
Stelara ® is indicated for vary of immunology indications and has recorded international gross sales of US$ 19 billion of which US$ 3.2 billion gross sales coming from Europe as per IQVIA MAT Jun’24 knowledge.
IMULDOSA ® has been below joint growth since 2013 by Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, Dong-A ST took over the R&D and commercialisation tasks to streamline international challenge administration. A yr later, the corporate signed a worldwide licensing settlement with Intas Prescribed drugs, paving the way in which for the biosimilar’s commercialisation by Accord BioPharma within the US and Accord Healthcare within the EU, UK, and Canada.
Dong-A ST said that its R&D experience has been reaffirmed by the constructive CHMP opinion, following the FDA approval for IMULDOSA. The corporate additionally added that it’s now targeted on a profitable launch of IMULDOSA in each the US and European markets, aiming to supply higher therapy choices for sufferers worldwide.
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