Stada's Silapo gets CHMP thumbs up

German generics group Stada Arzneimittel says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive approval recommendation for Silapo (erythropoietin-zeta). The committee said that the drug, which is a biosimilar version of Johnson & Johnson's anemia medication Eprex/Erypo (epoetin alfa), should be cleared for indications ranging from dialysis to oncology.

Originally developed by Bioceuticals Arzneimittel AG, a venture capital-funded operation set up by Stada to carry out its biosimilar programs, the drug will be sold in Germany by the two firms under a licensing agreement signed late last year (Marketletter November 27, 2006). Elsewhere in Europe and around the world, including the USA, distribution rights are held by US hospital products company Hospira, which will sell the drug under the Retacrit brand name, as stipulated by a separate deal with Bioceuticals.

Christof Schumann, a member of Stada's executive board, said that the firm was very pleased with the CHMP's conclusion, and that European Union-wide clearance for Silapo is expected in the current year. He added that, if approval is granted, Stada will be in a position to begin selling the drug in Germany in the first quarter of next year, likewise for Hospira in its licensed territories.