ACCORD

FDA Approved Biologics and Pending Applications

Accofil®

filgrastim
Accofil® Approval Pending

Hercessi

trastuzumab-strf
aBL 761346

Imuldosa

ustekinumab-srlf
aBL 761364

INTP23

denosumab
INTP23 Approval Pending

Pelgraz

pegfilgrastim
Pelgraz Approval Pending

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Accofil® (filgrastim) (Accord Healthcare) (September-2014)Pelgraz (pegfilgrastim) (Accord Healthcare) (September-2018)Sondelbay (teriparatide) (Accord Healthcare) (March-2022)Zercepac (trastuzumab) (Shanghai Henlius Biotech / Accord Healthcare Ltd.) (July-2020)

Biosimilars Approved In Australia

Neutropeg® (pegfilgrastim) (Accord Healthcare) (August-2019) Pelgraz® (pegfilgrastim) (Accord Healthcare) (December-2019)

U.S. Patent Litigations

NEUPOGEN / NEULASTA / GRASTOFIL / LAPELGA0:18-cv-61828 (S.D. Fla.)
PROLIA / XGEVA / INTP235:24-cv-00642 (E.D.N.C.)

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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