By Donald Zuhn --
Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) approved three new follow-on biologic drugs: Binocrit (Sandoz GmbH), Epoetin alfa Hexal (Hexal Biotech Forschungs GmbH), and Abseamed (Medice Arzneimittel Pütter GMBH & Co.). The approved biosimilars are generic versions of Johnson & Johnson's Eprex (marketed as Procrit® in the U.S.), which is based on the human protein erythropoietin (EPO). Like Eprex, the biosimilars are intended for the treatment of anemia associated with chronic kidney disease and in oncology patients and to reduce blood transfusion requirements in oncology patients and prior to elective orthopedic surgery.
The European Commission (EC), which usually follows the CHMP's recommendations, is expected to issue a formal decision on the three biosimilars within two months. If the EC approves Binocrit, it will be Sandoz' second approved biosimilar. Sandoz' Omnitrope (human growth hormone) was the first biosimilar to be approved in Europe, having received a positive opinion from the CHMP in January 2006.
For additional information regarding the approval, please see:
- Outsourcing Pharma's report
For additional information regarding this and other related topics, please see:
- "European Medicines Agency Releases Paper on Biosimilar Medicines," July 23, 2007
- "Senate Committee Passes Biologics Legislation," July 5, 2007
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