EC approves more biosimilars, Stada and Hospira's epoetin zeta

Following earlier positive opinions from the European Medicines Agency (EMEA), the European Commission has granted final marketing for two biosimilar epoetin zeta products, German drugmaker Stada Arzneimittel's Silapo and US firm Hospira's Retacrit, for the treatment of anemia associated with chronic renal failure and chemotherapy (Marketletter October 29, 2007).

Hospira has rights from Stada to develop, manufacture and distribute a biosimilar version of erythropoietin under a licensing deal (Marketletter November 27, 2007). The companies plan to launch their respective products in the European Union in early 2008.

The EMEA has developed a regulatory pathway to approve biosimilars in Europe, but a comparable Food and Drug Administration clearance system does not, as yet, exist in the USA, where the products are often referred to as "follow-on proteins" or "biogenerics." The US Congress is expected to continue to move the issue forward when it reconvenes for 2008.