FDA approves new use of first U.S.-approved follow-on biologic

PRINCETON, N.J. The FDA approved Sandoz Omnitrope (somatropin [rDNA origin]) as a treatment for idiopathic short stature, abnormally short stature not related to growth hormone deficiency, Sandoz announced Friday. The drug was already approved for growth failure in children, children small for gestational age and adults with growth hormone deficiency.

The FDA approved Sandoz' Omnitrope (somatropin [rDNA origin]) as a treatment for idiopathic short stature, abnormally short stature not related to growth hormone deficiency, Sandoz announced Friday. The drug already was approved for growth failure in children, children small for gestational age and adults with growth hormone deficiency.

“We are pleased to help make Omnitrope easier to access for a wider range of patients with growth-related conditions through the approval of a new indication and a new patient assistance program,” Sandoz president Don DeGolyer said in a statement. “Making Omnitrope easier to access and use are key components of our commitment to patients and will allow more patients to benefit from this high-quality biopharmaceutical.”

Omnitrope, a follow-on biologic that users Pfizer’s Genotropin as a reference product, received FDA approval in May 2006 under special circumstances. The healthcare reform bill creates a regulatory approval pathway for biosimilars in general, though the regulations have yet to be implemented.