ORGANON

FDA Approved Biologics and Pending Applications

Bildyos® / Bilprevda®

denosumab-nxxp
aBL 761444

Follistim® AQ

follitropin alfa/beta
BL 021211

Hadlima

adalimumab-bwwd
aBL 761059

HLX11

pertuzumab
HLX11 Approval Pending

Pregnyl®

chorionic gonadotropin
BL 017692

Tofidence

tocilizumab-bavi
aBL 761354

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Bildyos® / Bilprevda® (denosumab) (Organon / Shanghai Henlius Biotech) (September-2025)

U.S. Patent Litigations

PERJETA / HLX112:25-cv-14648 (D.N.J.)
PROLIA / XGEVA / BILDYOS / BILPREVDA1:25-cv-12160 (D.N.J.)

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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