Sandoz Gets EU Nod for Version of Amgen’s Neupogen

Novartis AG’s Sandoz unit won European approval for an anemia treatment similar to Amgen Inc.’s Neupogen, adding a second so-called biosimilar drug to boost the number of white blood cells to its range of products.
Sandoz, the only company with marketing authorization for more than one biosimilar, plans to start selling a lower-cost version of the Amgen medicine to help patients fend off life- threatening infections after chemotherapy, the Holzkirchen, Germany-based company said in an e-mailed statement today.

Neupogen and a newer version, Neulasta, belong to a class of medicines made from genetically manipulated cells, unlike conventional pills derived from chemical synthesis. Generic-drug makers are racing to introduce copies of expensive biotechnology treatments as patents expire and governments and insurers around the world try to rein in health-care spending.

Teva Pharmaceutical Industries Ltd., the world’s biggest maker of generic drugs, is ahead of Novartis, winning approval in Europe in September to begin selling its version of Neupogen. Teva developed the drug in cooperation with German drugmaker Ratiopharm GmbH.

Novartis became the first company to win European approval for a biosimilar when regulators cleared its version of the human growth hormone Omnitrope in April 2006. It also has approval to sell a version of Johnson & Johnson’s anemia drug epoetin alfa, also known as Eprex.

The controversial products are currently not authorized in the U.S., where biotechnology companies have argued that their products are too complex to be copied without risking side effects.