Alvotech Initiates Confirmatory Patient Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
Alvotech (NASDAQ: ALVO) has initiated a confirmatory patient study for AVT03, a biosimilar candidate to Prolia® and Xgeva®. The study aims to establish clinical similarity in efficacy and safety for treating osteoporosis in postmenopausal women. Prolia® and Xgeva® had combined sales of nearly $5.3 billion in 2021. The multicenter study will involve around 476 women, with results expected after 12 to 18 months. Alvotech, focused on biosimilars, seeks to enhance access to affordable biologic treatments globally.
- Initiation of confirmatory patient study for AVT03 is a significant milestone.
- The study aims to demonstrate similarity to Prolia® and Xgeva® in efficacy and safety.
- AVT03 targets a lucrative market, with combined sales of Prolia® and Xgeva® nearing $5.3 billion in 2021.
- AVT03 is still an investigational product and has not received regulatory approval.
- Biosimilarity has not been established, posing potential risks for market entry.
- Alvotech has now entered four biosimilar candidates into confirmatory patient studies
- Combined sales of Prolia® and Xgeva® (denosumab) which are used to treat bone diseases were nearly
$5.3 billion in 2021
Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT03 (denosumab), a biosimilar candidate to Prolia® and Xgeva®. The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia® in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis. The results from this trial will be used to support additional indications for AVT03 to Xgeva® based on extrapolation.
Prolia® (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture. Xgeva® (denosumab), which is the same biologic in a different presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone. In 2021, combined net revenues worldwide from sales of Prolia® and Xgeva® were nearly US
“We are proud to be able to initiate the confirmatory patient study for AVT03, adding another important milestone in the development of our biosimilars portfolio. Alvotech’s growing biosimilars pipeline shows our commitment to improving people’s lives globally by increasing access to cost-effective biologic medicines,” said Mark Levick, CEO of Alvotech.
The AVT03-GL-C01 multicenter study is of randomized double-blind parallel design, with repeat dosing and 2 arms. Approximately 476 volunteers, postmenopausal women 50 years or older diagnosed with osteoporosis, will be randomly assigned between the two arms. Each participant will receive three doses of either AVT03 or Prolia, at six-month intervals. The primary outcome measure will be to demonstrate clinical similarity of AVT03 and Prolia® in terms of change from baseline in markers for bone mass density (BMD). While the primary endpoint will be measured at 12 months, all participants will be followed until an end of study visit after 18 months from the initial dose.
Alvotech’s current biosimilars portfolio targets autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer. A biosimilar to Humira® (adalimumab) is already approved in Europe (Hukyndra®) and Canada (Simlandi®), and three biosimilar candidates including AVT03 have entered or completed confirmatory patient studies. The start of a pharmacokinetic study for AVT03 in healthy adult subjects was previously announced in July 2022.
About Alvotech
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.
About AVT03 (denosumab)
AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction. AVT03 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.
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