Accord Healthcare, Inc.

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

The European Medicines Agency’s human medicines committee again decided not to recommend the renewal of the conditional marketing authorization for PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna. The treatment has gone through multiple reviews by the committee. Friday’s decision is the fourth time the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended against the drug. The CHMP first decided against Translarna in September 2023, then confirmed that decision in January 2024, following a re-examination requested by PTC Therapeutics. In June, the committee reviewed the drug after the European Commission asked the committee to consider additional data — but the committee’s decision remained the same. PTC Therapeutics asked the committee again to reconsider in July, which led to this fourth decision. Since its initial authorization in 2014, PTC Therapeutics has carried out two more studies in an attempt to show the drug’s effectiveness. The first study failed to confirm the efficacy of the treatment, though the data suggested that a subgroup of patients — those with a progressive decline in their ability to walk — might see more efficacy. A second study did not reach statistical significance in that subgroup of patients. The drug will remain available while the EMA reviews CHMP’s recommendation. “CHMP again based its decision on the results of the primary analysis subpopulation of Study 041 instead of the totality of evidence for Translarna,” PTC Therapeutics CEO Matthew Klein said in a statement . Leerink Partners wrote Friday that they expect this to be “the final negative opinion,” adding that although PTC Therapeutics resubmitted an NDA to the FDA in late July, there have been no more updates in the US, and they “remain skeptical on the likelihood of US approval.” In addition to the Translarna decision, here’s a look at the medicines that CHMP recommended ahead of a potential thumbs-up from the European Commission:

Dong-A ST’s biologics license application (BLA) for Imuldosa, submitted in October 2023, is approved by the U.S. Food and Drug Administration SEOUL, South Korea I October 11, 2024 I Dong-A ST (President/CEO Jae-Hun Jung, KRX: 170900) announced on October 11 that Imuldosa™ (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara®, has won U.S. Food and Drug Administration (FDA) approval. As its second FDA-approved biosimilar after Sivextro® (tedizolid phosphate) in 2014, the company has once again demonstrated its R&D competence. The news comes following the FDA acceptance of the biologics license application (BLA) submitted by Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, in October 2023. Imuldosa is a biosimilar to Stelara, a blockbuster drug developed by Janssen Biotech Inc. for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. It is one of the highest-grossing biopharmaceuticals generating US$10.86 billion globally (IQVIA Accumulative Sales in 2023). Dong-A Socio Holdings and Meiji Seika Pharma began joint development for Imuldosa in 2013, and the rights for R&D and commercialization were transferred from Dong-A Socio Holdings to Dong-A ST in July 2020 for efficient project management. In July 2021, Dong-A ST and Meiji Seika Pharma signed a global license agreement with Intas Pharmaceuticals, who is set to commercialize the biosimilar with its global subsidiaries including Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. Accord Healthcare has also submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) in June 2023, which was accepted in the following month of July 2023. Dr. Jae-Hong Park, the Head of R&D at Dong-A ST commented, “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 U.S., the world’s largest pharmaceutical market, as we continue to develop innovative medicines to further strengthen our global presence.” SOURCE: Dong-A ST