BAD VILBEL, Germany and REYKJAVIK, Iceland, Jan. 10, 2024 (GLOBE NEWSWIRE) — Partners STADA and Alvotech announced that the European Commission has granted marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate for Stelara® (ustekinumab). The centralized marketing authorization of the first European biosimilar of ustekinumab is valid in all countries of the European Economic Area (EEA), including the 27 Member States of the European Union (EU), as well as Iceland, Liechtenstein and Norway.
This European marketing authorization for Uzpruvo paves the way for market entry as soon as possible, following the expiry in July 2024 of a European Supplementary Protection Certificate (SPC) for Stelara.
The €2. 5 billion (US$2. 7 billion) festival of biosimilars in the European market for ustekinumab can lead patients to this life-changing biologic treatment in the fields of gastroenterology, dermatology and rheumatology.
Bryan Kim, Global Head of Specialties at STADA, commented: “This first marketing authorization of the biosimilar ustekinumab in Europe has the potential to particularly expand patient access through competition. By adding to our existing list of six announced biosimilars , STADA hopes to offer European gastroenterologists, dermatologists and rheumatologists offer another cost-effective remedy option.
The European Commission’s decision to grant a marketing authorisation comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in November 2023 on the approval of Uzpruvo with the indications Crohn’s disease, psoriasis. and psoriatic arthritis.
As part of a strategic partnership that began in 2019, Alvotech is primarily responsible for the development and production of the ustekinumab biosimilar AVT04. STADA owns the advertising rights in Europe, where the company has already announced six approved biosimilars, adding gastrointestinal, dermatological and rheumatological indications. These come with a high-concentration citrate-free adalimumab biosimilar developed and advertised as a component of the partnership between Alvotech and STADA.
In February 2023, the partners announced that that the EMA had accepted their marketing authorization application for AVT04, based on a comprehensive package of analytical and clinical data. This included data from the AVT04-GL-301 confirmatory clinical, safety and efficacy study that met its primary endpoint, with results demonstrating therapeutic equivalence between AVT04 and Stelara in patients with moderate to severe chronic plaque-type psoriasis. Pharmacokinetic similarity was demonstrated in the AVT04-GL-101 study.
Ustekinumab is a human IgG1κ monoclonal antibody (mAb). Uzpruvo is produced in Sp2/0 cells by infusion, like the reference product Stelara. Ustekinumab selectively targets the p40 protein, a common component of the cytokines IL-12 and IL-23 that play a very important role in treating the immune system. mediated diseases such as Crohn’s disease, psoriasis, and psoriatic arthritis.
About STADA Arzneimittel AG STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company. STADA Arzneimittel AG sells its products internationally in around 120 countries. In the 2022 financial year, STADA generated an organizational profit of €3,797. 2 million and earnings before interest, taxes, depreciation and amortization (EBITDA) of €884. 7 million. As of December 31, in 2022, STADA hired 13,183 more people worldwide.
About Alvotech Alvotech is a biotechnology company founded by Robert Wessman and focused solely on the progression and production of biosimilar medicines for patients worldwide. Alvotech seeks to become a global leader in biosimilars by offering high-quality, cost-effective products and services, made possible through fully incorporated technology and extensive in-house capabilities. Alvotech’s current portfolio comprises eight biosimilar applicants for the treatment of autoimmune diseases, ocular disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to deliver global success and leverage local expertise in markets such as the United States, Europe, Japan, China and other Asian countries and major parts of South America, Africa and the Middle East. Alvotech’s commercial components are Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co. , Ltd (Japan), Advanz Pharma (EEA), Cipla/ Cipla Gulf/Cipla. Medicine. Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co. , Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India , Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co. , Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business component covers a unique set of products and territories. Unless otherwise indicated, Alvotech disclaims all responsibility for the content of periodic documents, disclosures and other reports made through its components. For more information, visit www. alvotech. com. None of the data on Alvotech’s online page will be considered part of this press release.
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