FDA Approves Extra U.S. Manufacturing Capacity for Alvotech’s Humira Biosimilar SIMLANDI
FDA cleared a second Reykjavik suite for SIMLANDI, doubling U.S. drug-substance capacity and confirming earlier inspection issues are resolved.
/ 6 items
#ALVO↓
Barclays Upgrades Alvotech to Overweight, Doubles Target to $8 Ahead of December FDA Decisions
Barclays now sees two-times upside vs. downside for ALVO into December FDA reviews of Simponi, Eylea and Prolia biosimilars.
Alvotech: BofA Initiates Buy Rating as Biosimilar Launch Cycle Begins
FDA clears Reykjavik plant as biosimilar launches drive commercial growth.
Alvotech Partners with Lotus on Biosimilars to Imfinzi and Hemlibra in the US and Asia
Alvotech partners with Lotus for biosimilars to Imfinzi and Hemlibra in the US and Asia. Deal worth up to $150M plus ongoing supply revenue.
FDA Accepts Alvotech’s AVT16 – A New Interchangeable Biosimilar to Entyvio
Alvotech’s AVT16 biosimilar to Entyvio is under FDA review, aiming for cheaper, interchangeable treatment for gut diseases.
Alvotech's Biosimilar Drug Faces FDA Setback Due to Manufacturing Issues
Alvotech receives FDA complete response letter for AVT05 biosimilar to Simponi, citing manufacturing facility deficiencies. Company revises 2025 revenue outlook downward.