EMEA Recommends Epoetin Alfa Biosimilars for Approval

June 28, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

London, UK (June 22)-The competition between biosimilars and branded drugs intensified this week thanks to favorable reviews of three biosimilar products for a popular treatment for anemia.

London, UK (June 22)-The competition between biosimilars and branded drugs intensified this week thanks to favorable reviews of three biosimilar products for a popular treatment for anemia. During a June 18–21 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the granting of marketing authorization for three products shown to be similar to “Eprex/Erypo” (epoetin alfa) manufactured by Janssen-Cilag, a subsidiary of Johnson & Johnson (New Brunswick, NJ). CHMP granted positive opinions to “Binocrit” from Sandoz GmbH (Holzkirchen, Germany), “Epoetin alfa Hexal” from Hexal Biotech Forschungs GmbH (Holzkirchen, Germany), and “Abseamed” from Medice Arzneimittel Puetter GmbH & Co.

Epoetin alfa is an injectable protein drug for treating anemia associated with chronic kidney disease and in oncology patients. It also is the active ingredient in Epogen (epoetin alfa recombinant) from Amgen (Thousand Oaks, CA) and Procrit (epoetin alfa) from Ortho Biotech (Bridgewater, NJ), a Johnson & Johnson Company.