Alvotech: FDA To Review BLA For AVT05 - Quick Facts

(RTTNews) - Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the FDA has accepted for review Biologics License Applications for AVT05, Alvotechs proposed biosimilar to Simponi and Simponi Aria, or golimumab, which are prescribed to treat a variety of inflammatory conditions. The company noted that these are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process is anticipated to be completed in the fourth quarter of 2025.

In 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotechs biosimilar product candidates, including AVT05. Since the companies entered into the strategic partnership, two biosimilars developed under the partnership have achieved FDA approval.

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