Ustekinumab biosimilar (Accord BioPharma)

LONDON, Dec. 16, 2024 /PRNewswire/ -- Accord announces that the European Commission (EC has granted marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar to Stelara®, indicated for a range of immune medicated inflammatory diseases. The EC approval follows a positive opinion issued on 19 October 2024 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union (EU) Member States plus Iceland, Norway and Liechtenstein. The CHMP positive opinion is based on a comprehensive package of analytical, non-clinical, and clinical similarity data, including a multi-regional phase III clinical trial in patients with plaque psoriasis. The study confirmed therapeutic equivalence, in the primary outcome, between DMB-3115 and Stelara®, alongside a comparable safety profile. The marketing authorisation paves the way for the launch of Imuldosa® in the EU ustekinumab market, valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA MAT June 2024 data. Intas holds exclusive licensing rights to commercialise Imuldosa® worldwide, excluding Japan, Korea, and certain other Asian countries. Imuldosa® was already approved by the USFDA on October 10, 2024. Accord Healthcare Limited (Accord) announces that the European Commission (EC) has granted marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar of Stelara® (ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which may play an important role in inflammatory and immune responses. Stelara® is indicated for range of immune medicated inflammatory diseases and has recorded global sales of US$ 19 billion of which US$D 3.2 billion sales coming from Europe as per IQVIA MAT Jun'24 data. Joe Dunford, VP of Speciality Brands stated, "Accord is committed to becoming a significant player in the autoimmune space, and we are delighted that the European Commission (EC) has granted marketing authorisation for our fifth biosimilar in Europe, Imuldosa®. This approval ensures that patients have access to high-quality therapies in Europe and beyond. We remain dedicated to advancing our biosimilar pipeline, with the goal of launching 20 biosimilars by 2030. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Accord announces that the CHMP has issued a positive opinion for Imuldosa® (development code: DMB-3115), a biosimilar to Stelara®, indicated for a range of immunology conditions. The approval of Imuldosa® further enhances Accord Healthcare's biosimilar portfolio and strengthens Accord's Autoimmune Franchise building on existing leading brands. Imuldosa® will be the 5th biosimilar for Accord in the EU, with a further 10 in various stages of development. LONDON, Oct. 19, 2024 /PRNewswire/ -- Accord Healthcare Limited (Accord) a subsidiary of Intas Pharmaceuticals, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar of Stelara® (ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which may play an important role in inflammatory and immune responses. Mr. Paul Tredwell, Executive Vice President of Accord Healthcare, said, "We are delighted with the positive CHMP opinion for Imuldosa®. This further strengthens our established autoimmune franchise, where Accord already has several leading speciality brands. The recommendation affirms Accord's continued strategy to expand its speciality business with an industry-leading portfolio, this positive opinion, combined with a further 10 biosimilars in development, reaffirms our commitment to improve access to value-based medicines for patients." "We are truly excited by this partnership which, besides strengthening our existing biosimilar portfolio, also reinforces our long-term commitment towards bettering access to medicines for patients globally," said Mr Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals Ltd. References for media: According to the EMA CHMP positive opinion, DMB-3115 is highly similar to the reference product Stelara® (ustekinumab) and has demonstrated comparable quality, safety and efficacy to Stelara®. The MAA submission includes results from the phase III multi-regional clinical trial in patients with plaque psoriasis (NCT04785326). The study demonstrated a comparable efficacy and safety profile between DMB-3115 and Stelara®. Stelara® is indicated for a 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 June 2024 data. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED