Alvotech will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02
The switch 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 for Humira and performed a switch study to support interchangeability
REYKJAVIK, Iceland, Nov. 10, 2022 (GLOBE NEWSWIRE) — Alvotech (NASDAQ:ALVO), a global biotechnology company focused on developing and manufacturing biosimilar medicines for patients worldwide, today announced that she will present two posters and be featured in an Ignite Talk related to her switch study for ATV02 at the American College of Rheumatology (ACR) Convergence Conference, to be held in Philadelphia November 10-14, 2022.
Posters and Ignite Talk will provide details of data from Alvotech’s switch study for ATV02, a proposed high strength (100 mg/mL) citrate-free interchangeable biosimilar candidate for Humira® (adalimumab), conducted to study pharmacokinetics (PK), immunogenicity, efficacy and safety in patients undergoing repeated switching between Humira and AVT02.
Alvotech is the only known company that has both developed a high concentration biosimilar candidate for Humira and completed a switching study to support potential regulatory approval as an interchangeable product. Alvotech’s Biological License Application (BLA) for interchangeability between ATV02 and Humira® was accepted by the United States Food and Drug Administration (FDA) in February 2022 and is currently under review by the FDA.
Demonstrating interchangeability of biosimilars with originator products is key to supporting clinical practice by reducing healthcare costs and increasing patient access to biologic therapies. The biosimilarity of AVT02 with Humira was previously evaluated in a Pharmacokinetic study and confirmatory efficacy and safety studywhich supported the biosimilarity assessment 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 Room on Saturday, November 12, 2022, from 1:00 p.m. to 3:00 p.m. 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 switching between Humira and AVT02will be presented in the Virtual Poster Room on Sunday, November 13, 2022, from 9:00 a.m. to 10:00 a.m. ET.
On Monday, November 14, 2022, at 2:15 p.m. ET, Steve Feldman, MD, Ph.D., Professor of Dermatology, Wake Forest University School of Medicine, will give an Ignite talk on the Downtown Stage titled “A clinical study designed to support a demonstration of interchangeability between AVT02 and the reference adalimumab (Humira®).”
Posters and presentation details will be available on the conference platform during the conference. More information on ACR’s Convergence 2022 conference is available here.
About AVT02 (adalimumab)
AVT02 is an approved monoclonal antibody and biosimilar to Humira® (adalimumab) in the EU, UK, Switzerland, Norway, Iceland, Lichtenstein (Hukyndra®) and Canada (Simlandi™). AVT02 files are under review in several countries, including the United States.
Alvotech is a biotechnology company, founded by Robert Wessman, which is solely focused on developing and manufacturing biosimilar drugs for patients worldwide. Alvotech seeks to be a global leader in the biosimilars space by providing high-quality, cost-effective products and services enabled by a fully integrated approach and extensive in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates for the treatment of autoimmune disorders, ocular disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to provide global reach and leverage local expertise in markets including the United States, Europe, Japan, China and other Asian countries and major parts from South America, Africa and the Middle East. Alvotech’s business partners include Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), 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, Tutor and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business partnership covers a unique set of product(s) and territories. Except as otherwise provided herein, Alvotech is not responsible for the content of periodic filings, disclosures and other reports made available by its partners. For more information, visit www.alvotech.com. None of the information on Alvotech’s website should be considered part of this press release.
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