FUJIFILM

FUJIFILM

approved_indications FDA Approved Biologics and Pending Applications

FKB238

bevacizumab
FKB238 Approval Pending

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Hulio® (adalimumab) (Viatris / Fujifilm Kyowa Kirin) (February-2021)

Biosimilars Approved In The E.U.

Hulio® (adalimumab) (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)

Biosimilars Approved In Japan

Adalimumab BS (adalimumab) (Fujifilm Kyowa Kirin Biologics / Viatris / Sandoz) (June-2020)Insulin glargine BS (insulin glargine recombinant) (Biocon / Fujifilm Pharma) (March-2016)

approved_indications U.S. Patent Litigations

AVASTIN / FKB2382:20-cv-00361 (E.D. Tex.)

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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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