Jubbonti® / Wyost®

JUBBONTI (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture; Treatment to increase bone mass in men with osteoporosis at high risk for fracture; Treatment of...

CT-P41

CT-P41 (denosumab) is not FDA-approved. An aBLA has been submitted to the FDA.

Ryzneuta®

RYZNEUTA (efbemalenograstim-alfa-vuxw) is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a...

Activase® / Cathflo® Activase®

ACTIVASE (alteplase) is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS); Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure; Acute Massive Pulmonary Embolism (PE) for lysis. CATHFLO...

Praluent®

PRALUENT (alirocumab) is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor indicated: To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease; As adjunct to...

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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