FDA approves Omnitrope

Sandoz's (Holzkirchen, Germany) recombinant human growth hormone, Omnitrope, has been approved by the US Food and Drug Administration (FDA) for treatment of growth disorders in children and adults through the 505(b)(2) pathway of the Hatch-Waxman Act, making it the first "biosimilar" drug to be approved in the US.

The decision follows the European Commission's approval of Omnitrope on April 19 and long-running indecision by the FDA, who received initial filing for the product in July 2003. The Agency announced in August 2004 that it had been unable to reach a decision on whether to approve the application, but as the Federal food Drug and Cosmetic Act and the Food Prescription Drug User Fee Act dictate that the FDA is required to either approve or reject new drug applications, Sandoz filed a lawsuit against the FDA in September 2005 seeking a ruling. On 10 April this year the US District Court for the District of Columbia granted summary judgment in Sandoz" favour, upholding the statutory deadline for FDA action on a pending new drug application and thereby enforcing the requirement of the FDA to issue a decision on the application.

"The FDA's approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for health care providers and patients worldwide," said Dr Andreas Rummelt, ceo of Sandoz, the generic arm of Novartis (Basel, Switzerland). "The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the US."

Omnitrope is a generic version of Pfizer's human growth hormone Genotropin and Serono's Saizen. Referring to the approval saga with the FDA, a Sandoz statement says that "rigorous scientific criteria should be consistently applied to the approval process for all follow-on biotechnology medicines", but adds that "these types of medicines should be approved and produced once patents have expired without specific reference to the trade secrets and confidential commercial information of innovators". The company has said that it expects biosimilars to play "a key role" in its future growth strategy.