FDA accepts BLA for AVT 02 adalimumab biosimilar from Alvotech.
Alvotech announced that the FDA has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT 02, a high-concentration, interchangeable biosimilar candidate to Humira (adalimumab). The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT 02 BLA. The BsUFA goal date provided by the FDA is February 24, 2024.
The FDA indicated that Alvotech’s resubmission is considered to be a complete response to the agency’s June 28, 2023, action letter, given the additional Chemistry, Manufacturing and Controls information submitted by the Company with the BLA to address manufacturing facility deficiencies identified earlier by the FDA.
An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the healthcare professional who prescribed the originator biologic, subject to variations in state pharmacy laws and practices. No interchangeable high-concentration adalimumab biosimilar is currently available to U.S. patients.
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