REG-Alvotech announces resubmission of U.S. Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and AVT06, a proposed biosimilar to Eylea®
Alvotech has resubmitted Biologics License Applications (BLAs) to the FDA for AVT05 (biosimilar to Simponi/Simponi Aria) and AVT06 (biosimilar to Eylea). The resubmissions follow the company's response to a Post-Application Action Letter regarding its Reykjavik manufacturing facility and a routine cGMP inspection completed in May 2026.
Key figures
- Drug Name
- AVT05, AVT06
- Review period
- six months
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