Trulicity®

TRULICITY (dulaglutide) is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus; To reduce the risk of...

Jemperli®

BL 761174: JEMPERLI (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Endometrial cancer: In combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary...

Pulmozyme®

PULMOZYME (dornase alfa) is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.

Kisunla

KISUNLA (donanemab-azbt) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which...

SB16

SB16 (denosumab) is not FDA-approved. An aBLA has been accepted by the FDA.

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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