Sandoz Wins EU Approval, US Progress for Biogeneric Product

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Sandoz (Holzkirchen, Germany), the generics division of Novartis (Basel, Switzerland) received European marketing authorization for its recombinant human growth hormone, ?Omnitrope? (somatropin), making it the first biogeneric product approved under the biosimilar pathway of the European Commission.

Sandoz (Holzkirchen, Germany,, the generics division of Novartis(Basel, Switzerland, received European marketingauthorization for its recombinant human growth hormone, "Omnitrope"(somatropin), making it the first biogeneric product approved under thebiosimilar pathway of the European Commission.

"As more biotechnology-based products come off patent, biosimilars willplay an increasingly important role by providing, lower-cost, safe andeffective versions of patent-expired biological medicines," saidAndreas Rummelt, Sandoz CEO in a company statement.

Omintrope is the first of several biosimilar products Sandoz ispursuing. Sandoz expects to begin marketing Omnitrope in Germany andAustria. The product is currently on the market in Australia, where itwas launched in November 2005.

Sandoz also is seeking approval for Omnitrope in the United States andgained a step-wise victory in its ongoing litigation with the US Foodand Drug Administration (Rockville, MD, over itsOmintrope application.

Sandoz reported this week that the US District Court for the Districtof Columbia granted summary judgment that upholds the statutorydeadline for FDA action on a pending new drug application, therebyrequiring FDA to issue a decision on Sandoz's application forOmnitrope, which was filed in July 2003. Sandoz had filed a lawsuitagainst FDA in September 2005, seeking a ruling on its Omnitropeapplication.

A second biogeneric for recombinant human growth hormone is underEuropean regulatory review. In February, the European MedicinesAgency's Committee on Medicinal Products for Human Use issued apositive recommendation for "Valtropin" (somatropin), a biosimilarproduct made by BioPartners GmbH (Baar, Switzerland,