Accord Healthcare, Inc.

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

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Coherus is resuming the supply of its Neulasta biosimilar after issues at a third-party labeling and packaging contractor caused delays in October. Production will resume this week. It has a backlog of around 120,000 units. Coherus first warned of supply delays in September. The biosimilar, branded as Udenyca, is approved to reduce infection in patients with low white blood cell count. Novavax has ended its Covid-19 vaccine supply agreement with the UK, the company said on Wednesday. The vaccine maker will return $10.3 million in quarterly installments over the next three years, totaling $123.8 million. Akebia Therapeutics disclosed in its third-quarter report that it has several ties with WuXi STA, a subsidiary of WuXi AppTec. The company has two contracts with WuXi and has the option to give 180 days notice to terminate them for any reason. One of the contracts ends in 2029 and the other in 2032. Charles River Laboratories reported a 1.6% drop in its total revenue for the third quarter of 2024 to $1.01 billion. But its manufacturing business increased 12% to $196.9 million because of heightened demand for its cell and gene therapy services, CEO James Foster said in an earnings call Wednesday. Charles River makes Vertex Therapeutics’ cell therapy Casgevy. The World Health Organization and its member states have allocated 899,000 doses of mpox vaccines to nine African countries. Around 85% of the doses will be supplied to the Democratic Republic of the Congo, which has the highest number of infections, according to a Wednesday release. CDMO AmplifyBio secured $50 million from investment capital provider Vitrian to bolster its manufacturing facility in New Albany, OH, according to a Tuesday release. Accord Healthcare received £50 million ($64.9 million) from the UK government to expand its facility in Fawdon, Newcastle upon Tyne, the company said Friday . It will build new manufacturing lines for an unnamed cancer drug and two autoimmune injectables. Around 50 new jobs will be added. Fujifilm Diosynth Biotechnologies has started the first phase of its factory expansion in Hillerød, Denmark, which will include adding six mammalian cell bioreactors, the company said Tuesday. The overall plan will be completed and operational by 2026. It will increase the facility to 51,500 square meters and add 2,200 new jobs. FujiFilm also said it signed a commercial manufacturing agreement with TG Therapeutics to make its therapy for relapsing forms of multiple sclerosis, according to a Monday announcement. Fujifilm will make Briumvi in Holly Springs, NC, which will be fully operational in 2025. Briumvi was FDA approved in December 2022. Evotec has sold an API manufacturing site in Halle, Germany, to Munich-based private equity firm Monacum Partners, the company said Tuesday. No financial details were disclosed. The CDMO Scorpius Holdings is partnering with Celltheon so it can offer cell line development and antibody discovery to its customers, according to a Monday announcement.

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