The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted and agreed to review applications seeking approval of AVT02, a Humira (adalimumab) biosimilar candidate.
The FDA is expected to make a decision in September 2021, while the EMA’s decision is expected by the end of next year.
“This is the next important step in our progression to realizing our goals of getting important medicines to more patients around the world,” Joseph E. McClellan, chief scientific officer of Alvotech, the treatment’s developer, said in a press release. “The filings were based on the results of a comprehensive development program and data package comprising of a totality of evidence demonstrating a high degree of similarity of AVT02 compared to its reference product.”
As a biosimilar, AVT02 has similar properties, safety, and efficacy as its reference biological treatment, Humira. Like generics of synthetic medications, biosimilars are typically less costly and provide patients with access to more treatment options.
Humira and its biosimilars such as Hulio and Amjevita are approved for the treatment of inflammatory disorders that include ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, plaque psoriasis, and forms of inflammatory bowel disease. Notably, currently approved Humira biosimilars will not be commercially available in the U.S. until 2023.
The proposed AVT02 formulation is a high concentration dose of 100 mg/mL that matches the latest Humira formulation and is expected to set AVT02 apart from other biosimilar competitors, according to Alvotech.
The company’s regulatory applications are based on positive results from two clinical trials. A Phase 1 study, AVT02-GL-101 (NCT03849313), evaluated the pharmacological properties and safety of AVT02 in comparison with Humira and found no meaningful difference between the two therapies. In the trial, a total of 390 healthy adult volunteers were randomly assigned to receive a single 40 mg subcutaneous (under-the-skin) injection of AVT02 or Humira.
In addition, the Phase 3 trial AVT02-GL-301 (NCT03849404), conducted in patients with moderate to severe chronic psoriasis, found that AVT02 is similarly effective, safe, and tolerable to Humira. The study enrolled 412 patients who were randomly assigned to receive either AVT02 or Humira as an 80 mg subcutaneous loading dose, followed by 40 mg every other week over 48 weeks.
“The comprehensive AVT02 development program has demonstrated key results comparatively to the reference product and we are extremely happy to have met our primary objectives,” said Kimber Poffenberger, senior vice president and global head of regulatory affairs at Alvotech.
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