Alvotech (ALVO) Form 6-K — Jun 4, 2026
Alvotech announced the resubmission of Biologics License Applications (BLAs) to the FDA for AVT05, a biosimilar to Simponi and Simponi Aria, and AVT06, a biosimilar to Eylea. This follows the company's response to a Post-Application Action Letter and a routine cGMP inspection of its Reykjavik facility in May 2026. The company expects the FDA to conduct a six-month review of these resubmitted applications. AVT05 and AVT06 are partnered with Teva Pharmaceutical Industries Ltd., which is responsible for commercialization, while Alvotech handles development and manufacturing.
Key figures
- Fda review period
- 6 months
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