AMNEAL

FDA Approved Biologics and Pending Applications

ADL-018

omalizumab
ADL-018 Approval Pending

Alymsys®

bevacizumab-maly
aBL 761231

Boncresa / Oziltus

denosumab-mobz
aBL 761456 / 761457

Fylnetra

pegfilgrastim-pbbk
aBL 761084

Inter Partes Review Proceedings

NEUPOGEN / NEULASTA / RELEUKO / FYLNETRAIPR2019-00791
IPR2019-00797
NEUPOGEN / NEULASTA / RELEUKO / GRASTOFIL / LAPELGA / FYLNETRAPGR2019-00001

U.S. Patent Litigations

NEUPOGEN / RELEUKO2:18-cv-03347 (D.N.J.)
PROLIA / XGEVA / BONCRESA / OZILTUS1:25-cv-17278 (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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