Alvotech: Feb. goal date for Humira biosimilar approval

 Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, 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 AVT02 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.

https://www.biospace.com/article/releases/alvotech-provides-u-s-regulatory-update-on-avt02-a-high-concentration-interchangeable-biosimilar-candidate-to-humira-adalimumab-/