Alvotech (ALVO) said Thursday it has resubmitted biologics license applications to the US Food and Drug Administration for two proposed biosimilars in partnership with Teva Pharmaceutical Industries (TEVA).
The regulatory fillings follow responses to a Post-Application Action letter and a recent manufacturing facility inspection in Reykjavik, Iceland, with the proposed drugs targeting chronic inflammatory issues and retinal disorders, the company said.
Teva will manage the commercial rollout for both medications, which are anticipated to undergo a six-month regulatory evaluation, it said.
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