Approval paves way for first biosimilar on European market

Sandoz" (Holzkirchen, Germany) recombinant human growth hormone, Omnitrope, will become the first "biosimilar" approved under the European Commission's biosimilar pathway to reach the European market, following the company's receipt of marketing approval from the Commision.

The decision follows the issuance of a positive opinion by the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) in January. Sandoz - the generic arm of Novartis (Basel, Switzerland) - expects to begin marketing once negotiations with government health authorities regarding pricing and other regulatory requirements have been successfully concluded. The product, which is already on the market in Australia following its approval for the treatment of growth disorders in children in September 2004 and launch in November 2005, is expected to make its European debut on the German and Austrian markets.

"Omnitrope is the first of several Biosimilar products that Sandoz is pursuing," said Dr Andreas Rummelt, ceo Sandoz. "As more biotechnology-based products come off patent, Biosimilars will play an increasingly important role by providing lower-cost, safe and effective versions of patent-expired biological medicines. We are committed to further development of this class of products as we anticipate the future needs of patients and physicians."

The situation for Omnitrope has proven to be much more complicated on the other side of the Atlantic. Following initial filing in July 2003 the US Food and Drug Administration (FDA) announced in August 2004 that it had been unable to reach a decision on whether to approve the Sandoz' application.

However, under the Federal food Drug and Cosmetic Act and the Food Prescription Drug User Fee Act the FDA is required to either approve or reject new drug applications, so in September 2005 Sandoz filed a lawsuit against the FDA seeking a ruling, and 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, thereby requiring FDA to issue a decision on the Omnitrope application.