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Home Industry News Novartis reports EC approval for biosimilar epoetin alfa

Novartis reports EC approval for biosimilar epoetin alfa

31st August 2007

Sandoz, a Novartis company, has announced that it has received approval for its biosimilar epoetin alfa from the European Commission as a treatment for patients suffering from low red blood cell count.

This decision follows a positive recommendation from the Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency in June, with this approval set to provide patients with a cost-effective alternative to existing therapies.

Biosimilar refers to a follow-on version of a previously approved recombinant biotechnology pharmaceutical, with biosimilar epoetin alfa indicated for use in patients receiving chemotherapy and those with renal anaemia.

Andreas Rummelt, chief executive officer of Sandoz, said: “We are pleased that the European Commission has taken the final step in approving our biosimilar epoetin alfa for marketing in Europe and we will quickly bring this product to market for the patients and physicians who need it.”

He added that the firm is dedicated to making available cost-effective biosimilars to existing compounds, with the company having a number of products in its drug development pipeline.

In February 2006, Sandoz received the first ever positive opinion in Europe for a biosimilar compound, receiving a recommendation from the CHMP for the human growth hormone Omnitrope.

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