EMA Confirms Acceptance of Marketing Authorization Application for a Proposed Biosimilar to Simponi

Alvotech and Advanz Pharma recently announced the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi (golimumab), a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to Simponi. The approvals process is anticipated to be completed in the fourth quarter of 2025.

“This is a welcome milestone for us, our partners, patients and caregivers, as we take one step closer to being able to offer access to biosimilar Simponi,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “We believe having the capability and know-how inhouse to utilize a host cell line and process also used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to Simponi.”

“The EMA’s acceptance of the application for AVT05 represents a significant step forward in expanding treatment options for patients with chronic inflammatory diseases across Europe,” said Nick Warwick, Chief Medical Officer of Advanz Pharma. “We are committed to improving patient access to high-quality biologic medicines.”

Alvotech and Advanz Pharma first announced in February 2023 that the companies had entered into a commercialization agreement, for AVT23, a proposed biosimilar to Xolair (omalizumab). In May this year, the partners announced an expansion of the strategic partnership, to include five additional biosimilar candidates being developed by Alvotech, AVT05, AVT16 a proposed biosimilar to Entyvio (vedolizumab) and three additional early stage biosimilar candidates which remain undisclosed.

In April 2024 Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis. In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult participants.

AVT05 is a biosimilar candidate for Simponi and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

AVT16 is a human monoclonal antibody and a biosimilar candidate to Entyvio (vedolizumab). AVT16 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.

AVT23 is a monoclonal antibody and proposed biosimilar to Xolair (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars to Humira (adalimumab) and Stelara (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med 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 commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, visit https://www.alvotech.com.

Partner of choice in specialty, hospital, and rare disease medicines, Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.