Alvotech to Present Switching Study Data for AVT02, a Proposed Biosimilar to Humira®, at 2022 American College of Rheumatology Conference
- Alvotech will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02
- The switching study was conducted to investigate the pharmacokinetics, immunogenicity, efficacy and safety in patients undergoing repeated switches between Humira and AVT02
- Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support interchangeability
REYKJAVIK, Iceland, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02 at the American College of Rheumatology (ACR) Convergence Conference, being held in Philadelphia on November 10-14, 2022.
The posters and Ignite Talk will provide detail on the data from Alvotech’s switching study for ATV02, a proposed high-concentration (100 mg/mL), citrate-free interchangeable biosimilar candidate for Humira® (adalimumab), conducted to investigate the pharmacokinetics (PK), immunogenicity, efficacy and safety in patients undergoing repeated switches between Humira and AVT02.
Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support potential regulatory approval as an interchangeable product. Alvotech’s Biologics License Application (BLA) for interchangeability between ATV02 and Humira® was accepted by the US Food and Drug Administration (FDA) in February 2022 and is currently under review by the FDA.
Demonstration of interchangeability of biosimilars with originator products is a key component in supporting clinical practice by reducing healthcare costs and increasing patient access to biologic therapies. The biosimilarity of AVT02 to Humira has been previously assessed in both a PK study and a confirmatory efficacy and safety study, which supported the assessment of biosimilarity of AVT02.
Alvotech’s poster titled “A Clinical Study Designed to Support a Demonstration of Interchangeability Between AVT02 and Humira®” will be presented in the Virtual Poster Hall on Saturday November 12, 2022, from 1:00 – 3:00 PM Eastern Time (ET).
A second poster titled “Ex vivo Comparative Immunogenicity Assessment (EVCIA) to Determine Relative Immunogenicity in Chronic Plaque Psoriasis in Participants Receiving Humira® or Undergoing Repeated Switches Between Humira and AVT02” will be presented in the Virtual Poster Hall on Sunday November 13, 2022, from 9:00 – 10:00 AM ET.
On Monday November 14, 2022, at 2:15 PM ET, Steve Feldman, MD, Ph.D., Professor of Dermatology, Wake Forest University School of Medicine will give an Ignite Talk on the Center City Stage titled “A Clinical Study Designed to Support a Demonstration of Interchangeability between AVT02 and Reference Adalimumab (Humira®).”
Posters and presentation details will be available to view on the conference platform during the conference. Further information about the ACR’s 2022 Convergence conference can be found here.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and an approved biosimilar to Humira® (adalimumab) in the EU, the United Kingdom, Switzerland, Norway, Iceland, Lichtenstein (Hukyndra®) and Canada (Simlandi™). AVT02 dossiers are under review in multiple countries, including the United States.
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. Alvotech’s current pipeline contains eight 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), 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, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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