European regulators on June 22nd stepped up their approval of biosimilars -- drugs designed to compete with established biologics that no longer have patent protection -- by recommending sale in Europe of three new anemia drugs.

The Committee for Medicinal Products for Human Use of the European Medicines Agency said all three follow-on biologics "have been shown to be similar" to Johnson & Johnson's Eprex / Erypo, marketed in the United States as Procrit, in the treatment of anemia in patients with kidney disease or cancer.

The EMEA customarily issues a formal approval of the CHMP recommendations allowing the start of sale of drugs in the European Union countries approximately two months later.

The three biosimilars recommended for sale by the EMEA are:

• Binocrit (Epoetin alfa), from Sandoz GmbH;
• Epoetin alfa Hexal (Epoetin alfa), from Hexal Biotech Forschungs GmbH; and
• Abseamed (Epoetin alfa), from Medice Arzneimittel Pütter GMBH & Co.

The CHMP, which first approved sale of biosimilars in Europe a year ago, said review of the three follow-on was initiated on March 29th of 2006 and the active review period took 205 days.

The U.S. Congress is continuing to struggle with its effort to establish a regulatory pathway that would allow the Food and Drug Administration to approve the sale of follow-on biologics in the United States.