UPDATE: Sandoz' biosimilar epoetin cleared in EU

Swiss drug major Novartis' generics unit Sandoz has become the first company to develop and receive European Commission approval for its biosimilar epoetin alfa, achieving another important milestone in its efforts to bring cost-effective biological medicines to patients. On the day of the approval, August 31, shares in Novartis rose 1.2% to $52.84.

The EC's decision to clear the drug followed a positive opinion in June from the European Medicines Agency's (EMEA) Committee on Medicinal Products for Human Use (CHMP), which reviews medicines scientifically for the Commission (Marketletter July 2).

More than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names to regulate the formation of red blood cells. Worldwide annual sales are estimated at more than $7.0 billion, including $600.0 million in Europe, according to a Novartis statement.