VIATRIS

FDA Approved Biologics and Pending Applications

Hulio®

adalimumab-fkjp
aBL 761154

MYL-1402O

bevacizumab
MYL-1402O Approval Pending

MYL-1601D

insulin aspart
MYL-1601D Approval Pending

Semglee®

insulin glargine-yfgn
aBL 210605 / aBL 761201

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Abevmy (bevacizumab) (Biocon / Viatris) (November-2021)Hulio® (adalimumab) (Viatris / Fujifilm Kyowa Kirin) (February-2021)Kirsty (BGP Pharma (Viatris)) (October-2021)

Biosimilars Approved In The E.U.

Abevmy (bevacizumab) (Biocon / Viatris) (April-2021)Hulio® (adalimumab) (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)Kirsty (previously Kixelle) (insulin aspart) (Viatris / Biocon) (February-2021)

Biosimilars Approved In Japan

Adalimumab BS (adalimumab) (Fujifilm Kyowa Kirin Biologics / Viatris / Sandoz) (June-2020)

Inter Partes Review Proceedings

EYLEA / YESAFILIIPR2021-00880
IPR2021-00881
IPR2022-01225
IPR2022-01226
IPR2023-00099
IPR2024-00201
IPR2024-00298

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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