FDA Approved Biologics and Pending Applications
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Jamteki (ustekinumab) (Alvotech / JAMP Pharma) (November-2023)Simlandi (high-concentration adalimumab) (Alvotech / JAMP) (January-2022)
Biosimilars Approved In The E.U.
Gobviaz® (golimumab) (Alvotech / Advanz) (UK, EU: November-2025)Kefdensis / Zvogra, Acvybra / Xbonzy (denosumab) (Alvotech / STADA / Dr. Reddy's) (November-2025)Libmyris / Hukyndra (high-concentration adalimumab) (Stada Arzneimittel AG / Alvotech) (November-2021)Mynzepli (aflibercept) (Advanz Pharma / Alvotech) (August-2025)Uzpruvo® (ustekinumab) (Alvotech / STADA Arzneimittel) (January-2024)
Biosimilars Approved In Australia
Ciptunec / Ardalicip (high-concentration adalimumab) (Alvotech / Cipla) (November-2022)
Biosimilars Approved In Japan
AVT03 (denosumab) (Alvotech / Fuji Pharma) (September-2025)AVT04 (ustekinumab) (Alvotech / Fuji Pharma) (September-2023)AVT05 (golimumab) (Alvotech / Fuji Pharma) (September-2025)AVT06 (aflibercept) (Alvotech / Fuji Pharma) (September-2025)
Inter Partes Review Proceedings
U.S. Patent Litigations
HUMIRA / SIMLANDI1:21-cv-02258 (N.D. Ill.)1:21-cv-02899 (N.D. Ill.)1:21-cv-05645 (N.D. Ill.) (transferred from 2:21-cv-00265 (E.D. Va.))PROLIA / XGEVA / AVT031:25-cv-17277 (D.N.J.)
