Alvotech resubmits FDA biosimilar applications for Simponi, Eylea candidates

Alvotech

Alvotech

ALVO

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  • Alvotech resubmitted FDA BLAs for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea.
  • The refilings follow responses to an FDA Post-Application Action Letter tied to the Reykjavik manufacturing site.
  • The FDA is expected to complete a six-month review of the resubmitted applications.
  • Teva leads commercialization under the partnership.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alvotech SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606040400PRIMZONEFULLFEED1001185831) on June 04, 2026, and is solely responsible for the information contained therein.

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