Positive Results from a Pharmacokinetic Similarity Study for a proposed biosimilar to Stelara®
Alvotech announces a positive results from a pharmacokinetic similarity study for AVT04, a proposed biosimilar to Stelara®
Results from pharmacokinetic (PK) similarity study demonstrate bioequivalence of AVT04 (ustekinumab) to the reference product Stelara®
Alvotech Holdings S.A. (“Alvotech”), a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab).
The PK similarity study (AVT04-GL-101) utilized a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04, with US-licensed Stelara®, as well as EU-approved Stelara®. The study results demonstrated bioequivalence between AVT04 and the reference products.
Róbert Wessman, founder and Chairman of Alvotech
We are delighted at the continued progress of our pipeline of biosimilar candidates. This continued progress demonstrates the strength of Alvotech’s purpose-built biosimilar platform.
Ustekinumab is a human IgG1k monoclonal antibody that binds with specificity to the p40 protein subunit used by both the interleukin-12 and interleukin-23 cytokines. Stelara® is prescribed to treat a variety of inflammatory conditions including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. In 2021, Stelara’s worldwide net sales exceeded US$9 billion, making it one of the highest grossing biologic medicines. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT04 in the United States. STADA is Alvotech’s exclusive strategic partner for AVT04 for the European market.
Joseph McClellan, Chief Scientific Officer
We are pleased with the successful outcome of the AVT04 PK similarity study and the continued progress of our overall pipeline. We expect the results from our confirmatory efficacy and safety study for AVT04 before the end of the 2nd quarter.
Alvotech’s product portfolio includes AVT02, a biosimilar to Humira® (adalimumab). In addition to AVT04, Alvotech is advancing six other biosimilar candidates, using its highly integrated platform for development and manufacturing. Alvotech has established a global network of commercial partnerships in major markets, with the goal of expeditiously delivering its cost-effective biosimilar medicines to patients worldwide.
On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., (“OACB”) announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol “ALVO.” On May 11, 2022, Alvotech and OACB announced that the extraordinary general meeting of shareholders of OACB to approve the pending business combination between Alvotech, OACB and the legal entity named Alvotech, previously named Alvotech Lux Holdings S.A.S., (“TopCo”) is scheduled to be held on June 7, 2022.
About the AVT04-GL-101 pharmacokinetics, safety, and tolerability study
The AVT04-GL-101 pharmacokinetic (PK) study was conducted in Australia and New Zealand and enrolled 294 healthy adult volunteers. The study involved a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04, with US-licensed Stelara®, as well as EU-approved Stelara®.
For more information visit Alvotech's website.