Sandoz Receives Biosimilar Approval for Epoetin Alpha

Sandoz (Holzkirchen, Germany), a division of the Swiss pharmaceutical company Novartis, has become the first company to receive European Commission approval for a biosimilar of epoetin alpha. The approval was indicated for the use of biosimilar epoetin alpha in treating patients with renal anemia as well as those receiving chemotherapy.

This approval is the third approval of a biosimilar in Europe, following Sandoz’s April 2006 approval of Omnitrope (human growth hormone) and Biopartners’ May 2006 approval of its biosimilar human growth hormone, Valtropin.

Epoetin alpha, an erythropoiesis-stimulating agent (ESA) used to stimulate the formation of red blood cells in patients suffering from anemia caused by chemotherapy and kidney disease, is currently sold under various brand names, including Amgen’s Aranesp (darbepoetin alpha) and Epogen (epoetin alpha) and Johnson & Johnson’s Procrit (epoetin alpha).

Sandoz estimates worldwide annual sales of epoetin alpha at more than US$7 billion, including US $600 million in Europe. US sales of the drug have dropped significantly this year, however, after studies associated the drug with an increased risk of heart attacks, death, and tumor growth. Those studies led to FDA-mandated “black box” safety warnings on the label in early March, and reimbursement reductions by the Centers for Medicare and Medicaid Services (CMS) in late July. On August 15, Amgen announced restructuring as a result of lower Aranesp revenues, saying it would lay off as much as 12 to 14% of its staff (up to 2,600 people).

A joint meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee was held on September 11 to discuss the drug’s use in chronic renal failure. As reported by the Wall Street Journal, the panel voted 14-5 against labeling changes.

Although not required to follow the committees’ recommendations, the agency usually does. The recommendations may also be considered by CMS when making reimbursement decisions.