BOEHRINGER INGELHEIM

BOEHRINGER INGELHEIM

approved_indications FDA Approved Biologics and Pending Applications


Cyltezo®

adalimumab-adbm
aBL 761058

Praxbind®

idarucizumab
BL 761025

Spevigo®

spesolimab-sbzo
BL 761244

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Abasaglar (insulin glargine recombinant) (Eli Lilly / Boehringer Ingelheim) (September-2014)Cyltezo (adalimumab) (Boehringer Ingelheim) (November-2017)

Biosimilars Approved In Japan

Insulin glargine BS (insulin glargine recombinant) (Eli Lilly / Boehringer Ingelheim) (December-2014)

approved_indications Inter Partes Review Proceedings


RITUXANIPR2015-00415
IPR2015-00417
IPR2015-00418
SKYRIZIPGR2022-00037
HUMIRA / CYLTEZOIPR2016-00408
IPR2016-00409

approved_indications U.S. Patent Litigations


HUMIRA / CYLTEZO1:17-cv-01065 (D. Del.)

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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