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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.
More on Alvotech, Johnson & Johnson, etc.
- Why We Increased The Position In Johnson & Johnson
- Johnson & Johnson (JNJ) Presents at Bernstein 42nd Annual Strategic Decisions Conference Transcript
- Teva's Growth Story Is No Longer Just Generic, It's Getting Branded
- Regeneron backed Parabilis seeks up to $476M in U.S. IPO
- CytomX gains as licensing deal with Regeneron expands
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