Alvotech Initiates Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva® | New

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  • Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone diseases, with combined sales of nearly US$5.3 billion in 2021
  • AVT03 (denosumab) is the 4th product in Alvotech’s portfolio to enter clinical studies

REYKJAVIK, Iceland, July 20. 10, 2022 (GLOBE NEWSWIRE) — Alvotech (NASDAQ:ALVO), a global biotechnology company focused on developing and manufacturing biosimilar medicines for patients worldwide, today announced the initiation of a pharmacokinetic study for AVT03. (denosumab), a candidate biosimilar to Prolia® and Xgeva®. The clinical study will evaluate the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects.

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 the prevention of skeletal events such as pathologic fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumors of bone. In 2021, the combined worldwide net revenue from sales of Prolia® and Xgeva® was nearly US$5.3 billion1.

“The rapid progress in the development of our product portfolio illustrates the capabilities of Alvotech’s biosimilars platform. This milestone of the AVT03 program is another step in our important mission to improve lives by expanding access to affordable biologic medicines,” said Joseph McClellan, Chief Scientific Officer.

Alvotech’s current portfolio of eight products and product candidates targets the treatment of autoimmune diseases, ocular disorders, osteoporosis, respiratory diseases and cancer. Of these, four products have been launched or have entered clinical studies. Alvotech launched its first marketed product AVT02 (adalimumab), a biosimilar to Humira®, in Europe and Canada. In May, Alvotech announced positive initial results from a confirmatory, safety and efficacy clinical study and pharmacokinetic (PK) study for AVT04 (ustekinumab), a proposed biosimilar to Stelara®. In July, Alvotech announced the launch of a confirmatory clinical study for AVT06 (aflibercept), a proposed biosimilar to Eylea®.

1Based on manufacturer’s reported sales

About Alvotech

Alvotech specializes in the manufacture of biosimilars, to improve lives by expanding access to affordable biologic medicines. Founded by Robert Wessman, Alvotech seeks to be a global leader in biosimilars by providing high-quality, cost-effective biologics enabled by a vertically integrated approach from R&D to fill-and-finish manufacturing. To enable global reach, Alvotech has formed a network of strategic business partnerships in over 90 countries, in the United States, Canada, Europe, Asia, Latin America, Africa and the Middle East. Alvotech’s current portfolio of eight biosimilars and biosimilar candidates includes AVT02 (adalimumab), a Humira® biosimilar that is approved and marketed in Europe (Hukyndra®) and Canada (Simlandi®) and seven biosimilar candidates targeting immunology , oncology, respiratory disease, bone disease and ophthalmology. For more information, visit www.alvotech.com.

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, leading to a reduction in osteoclast number 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. Biosimilarity has not been established by regulatory authorities and is not claimed.

About AVT02 (adalimumab)

AVT02 is a monoclonal antibody and a biosimilar to Humira® (adalimumab), which inhibits tumor necrosis factor (TNF). AVT02 is not approved outside the EU, Norway, Iceland, Lichtenstein, UK, Switzerland and Canada. AVT02 files are being examined in several countries; in the United States, the original BLA for approval as a biosimilar is in deferred status, pending finalization of the BLA application review.

About AVT04 (ustekinumab)

AVT04 is a monoclonal antibody and biosimilar candidate to Stelara® (ustekinumab). Ustekinumab binds to two cytokines called interleukin-12 and interleukin-23 that are involved in inflammatory and immune responses. Abnormal regulation of these cytokines has been linked to immune-mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. AVT04 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.

About AVT06 (aflibercept)

AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept). Aflibercept binds to vascular endothelial growth factors (VEGF), inhibiting VEGF receptor binding and activation, neovascularization and vascular permeability. AVT06 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.

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