Alvotech resubmits FDA BLAs for AVT05 and AVT06 biosimilars
Alvotech resubmits FDA BLAs for AVT05 and AVT06 biosimilars, driving 18% surge
- On June 4, 2026, Alvotech announced resubmission of BLAs for AVT05 (biosimilar to Simponi/Simponi Aria golimumab) and AVT06 (biosimilar to Eylea aflibercept 2mg).
- Resubmissions follow resolution of prior manufacturing issues, CRLs, and FDA cGMP inspection with Form 483 at Reykjavik facility.
- Company implemented enhancements to quality systems and processes; expects standard 6-month FDA review with potential approvals in 2026.
- AVT06 targets major Eylea market for retinal disorders; AVT05 addresses inflammatory conditions; both partnered with Teva for U.S. commercialization.
- News aligns with prior guidance for June resubmissions, viewed as key pipeline milestone advancing toward revenue-generating approvals.
- Stock rose from prior close of ~$3.14 to intraday ~$3.68 (+17.97%), with elevated volume confirming catalyst impact per MarketWatch and news wires.
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