Novartis AG, the world's second- biggest maker of generic drugs, became the first company to win approval for a copy of Johnson & Johnson's Eprex anemia treatment, allowing it to offer cheaper versions to Europeans.
The European Commission cleared the biogeneric version of the drug known as epoetin alfa, Basel, Switzerland-based Novartis said today in a statement on Hugin newswire.
Novartis is first in a race among generic companies including Germany's Stada Arzneimittel AG to enter the $7 billion market dominated by Johnson & Johnson and Amgen Inc's branded versions of the drug. Novartis's generic-drug unit, Sandoz, sued U.S. regulators last year to win approval to copy the human growth hormone.
``We will quickly bring this product to market for the patients and physicians who need it,'' Sandoz Chief Executive Officer Andreas Rummelt said in the statement.
The approval, which follows a positive opinion on the product by a European Medicines Agency panel in June, covers the treatment of renal anemia and chemotherapy patients.
Novartis shares rose 50 centimes, or 0.8 percent, to 63.75 Swiss francs at the close of trading in Zurich. They've dropped 9.3 percent this year.
Companies are pushing to bring out copies of biological medicines as drugs go off patent and governments cut health-care budgets. Europe leads the U.S. in approving biogenerics, which are copies of medications made through biotechnology.
Biotech medicines are harder to make because they're genetically engineered versions of human proteins such as insulin or growth hormone, and produced in bacterial cells.
Anemia is a lack of oxygen-carrying red blood cells that produces weakness and fatigue. The drugs made by Amgen and J&J are copies of erythropoietin, a protein made by the kidneys that increases the number of red blood cells.
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