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For managing patients with
chronic plaque psoriasis, the Biologics License Application (BLA) of AVT02 has
been accepted for United States Food and Drug Administration (US-FDA) review.
As per the announcement on 19 November 2020, the US-FDA has accepted for review the BLA for AVT02, a biosimilar to adalimumab; with elevated concentration (100 mg/ml) dosage forms. Furthermore, the European Medicines Agency (EMA) has granted its acceptance to review AVT02's Marketing Authorization Application (MAA).
This monoclonal antibody has been demonstrated to be highly comparable to the reference product regarding structure and function. The submission of BLA is aided by data from a phase I pharmacokinetics similarity trial (AVT02-GL-101) and a phase III comparative safety and efficacy trial (AVT02-GL-301). AVT02 is anticipated to be valuable to patients and to be differentiated from most biosimilar competitors while matching the novel dose forms of the reference product.
The phase I trial determined the tolerability, pharmacokinetics, and safety of the investigational agent compared to adalimumab at a single dose of 40 mg in 392 healthy adult participants. The results depicted no clinically significant differences between AVT02 and adalimumab. Furthermore, the double-blind phase III trial assessed the immunogenicity, safety, and efficacy of the investigational agent to adalimumab in 412 adult subjects suffering from moderate-to-severe chronic plaque psoriasis.
Participants were randomly allocated (1:1) to either AVT02 or adalimumab with an initial loading dose of 80 mg subcutaneously. This was subsequently followed by 40mg once every other week until the 48th week. The outcomes from the phase III trial demonstrated that AVT02 fulfilled the primary outcome parameter attaining therapeutic equivalence to adalimumab as estimated by the Psoriasis Area and Severity Index (PASI) percent improvement at 16th week.
Furthermore, no substantial differences were noted between the investigational
agent and adalimumab on the secondary outcome parameters, including
immunogenicity, safety, tolerability, and serum trough levels at the
steady-state through the entire trial period. The FDA is anticipated to decide
on the application in September 2021 while the EMA's decision is expected in
the fourth quarter of 2021.
Biosimilar Development
Alvotech Announces That The U.S. FDA And EMA Have Accepted Regulatory Submissions For AVT02, A Proposed Biosimilar To HUMIRA (adalimumab)
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