Alvotech再次寻求美国批准强生的Thomoni和Regeneron的Eylea的生物仿制药

2026-06-05 02:34

Alvotech (ALVO) shares spiked on Thursday after the company announced the resubmission of U.S. marketing applications for biosimilars AVT05 and AVT06 targeting Johnson & Johnson’s (JNJ) Simponi and Regeneron’s (REGN) Eylea, respectively.
AVT05 is designed as an off-patent version of JNJ's arthritis therapy, developed for both subcutaneous and intravenous administration. AVT06 is an intravitreal injection targeting Eylea (aflibercept) 2 mg, a blockbuster eye therapy developed by Regeneron (REGN) and Bayer (BAYRZ).
The Biologics License Applications for AVT05 and AVT06 developed by the Iceland-headquartered drugmaker in partnership with Teva Pharmaceutical (TEVA) were denied FDA approval late last year due to manufacturing concerns.
Alvotech (ALVO) has refiled the BLAs, including responses to an FDA’s Post-Application Action Letter and an FDA inspection completed in May 2026 at its Reykjavik manufacturing facility. The resubmitted BLAs are expected to undergo a six-month review at the FDA.

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