Inflammatory disease
ALVOAlvotechCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for AVT05 (Proposed Biosimilar to Simponi® & Simponi Aria® (golimumab)) in Inflammatory disease. The expected timing is based on the latest available company guidance and may change.
Collab w/ Teva. 1/27/25- FDA accepted for review of BLA. 8/13/25- Regulatory review ongoing. 9/22/25- EU recommends marketing approval. 11/2/25- FDA issued CRL. 03/18/26:- AVT05 approved as Simponi biosimilar in UK and EEA; FDA resubmission expected Q2 2026. 05/06/26:- PR No update. 06/04/26:- FDA BLA resubmitted; FDA expects six-month review. PDUFA decision expected December 2026 (Est). 08/19/26:- AVT05 U.S. BLA resubmission was reiterated. FDA decision is anticipated in Q4 2026.
Verification
Confirm timing and program details against the company announcement or filing.