First biosimilar cleared in European Union

Novartis’ generics subsidiary Sandoz has become the first company to win approval of a biosimilar product in the European Union, after winning a green light for its Omnitrope human growth hormone product. Omnitrope was approved under a new regulatory framework that, for the first time, allows copycat versions of biologic drugs to be approved for marketing without a complete dossier of clinical data. Sandoz said it expects to begin marketing the product soon, following negotiations with government health authorities regarding pricing and other regulatory requirements. The drug is a copycat version of Pfizer’s Genotropin (somatropin) which had worldwide sales of $239 million last year. It will first be made available in Germany and Austria, said the company. It is currently on the market in Australia, where it was launched in November 2005. "We will quickly bring this product to market for the patients and physicians who need it,"said Andreas Rummelt, Sandoz' chief executive. "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." European approval adds to pressure on the US Food and Drug Administration (FDA), which has been sued by Sandoz for dragging its heels on an application to market Omnitrope. Earlier this week, a federal judge ordered the FDA to deliver a verdict on the dossier, which was filed in July 2003. The agency said it had completed its review in 2004 but had deferred ruling on the application until it has finalised its own guidance on biogenerics, referred to as ‘follow-on biologics’ in US regulatory parlance. The judge said that the FDA had to move ahead with setting out a clear regulatory framework for this type of product in the US market. Rummelt urged the FDA to follow the European Medicines Agency’s lead and approve Omnitrope, "acknowledging the sound science that supports this product." European approval of Omnitrope is expected to be a forerunner to registration of a number of other biosimilars. An application to market another biosimilar version of human growth hormone has been filed with the EMEA by Swiss company BioPartners, which has also submitted a dossier for interferon alpha, a treatment for hepatitis.