Elelyso®

ELELYSO (taliglucerase alfa) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease.

Saizen®

SAIZEN (somatropin) is a recombinant human growth hormone indicated for: Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD); Adult: Treatment of adults with either adult onset or childhood onset GHD.

Zomacton®

ZOMACTON (somatropin) is a recombinant human growth hormone indicated for: Pediatric: Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, idiopathic short...

Serostim®

SEROSTIM (somatropin) is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance.

Forteo®

FORTEO (teriparatide) is recombinant human parathyroid hormone analog (1-34), [rhPTH(1-34)] indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture; Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk...

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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