FDA accepts Teva, Alvotech BLAs for Simponi biosimilars

The FDA has accepted Alvotech (NASDAQ:ALVO) and Teva’s (NYSE:TEVA) Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria.

Review of the applications is expected to by completed in Q4 2025, according to