BioWorld International Correspondent
BRUSSELS, Belgium - The European Union has added to the growing range of generic biotechnology products available in Europe by authorizing three presentations of epoetin alfa.
The products are Binocrit, from Sandoz GmbH; Abseamed, from Hexal Medice Arzneimittel Pütter GmbH&Co; and Epoetin alfa Hexal, from Hexal Biotech Forschungs GmbH.
All three products are copies of Amgen's Erypo/Eprex, and have been authorized under the recently adopted European procedures for dealing with abridged applications for generic biopharmaceuticals, or biosimilars, which is allowed when much of the application can be based on a previously approved product.
The European authorities have accepted that the products match the previously approved reference product in terms of quality, safety and efficacy, and have granted marketing authorizations for treating anemia in patients suffering from chronic renal deficiency, and in oncology patients. The decision comes after a positive scientific opinion issued in June by the European Medicines Agency.
"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," said Andreas Rummelt, CEO of Sandoz, a division of the Novartis group. "We are committed to continue making high-quality and cost-effective biosimilars available and have several projects in our pipeline."
The decision also was welcomed by the European Generic Medicines Association, which has conducted a long battle to open up the European market to biosimilars. That has come in the face of strenuous opposition from innovator companies on grounds of safety and of intellectual property - particularly to limit the use of international nonproprietary names.
"These approvals definitely clarify for our industry the issue of assigning INNs for biosimilar medicines," said Suzette Kox, the association's director for scientific affairs. She interpreted the approvals as "further evidence that the necessary science and technology are indeed available to develop biosimilar medicines of larger, more complex protein molecules."
The European Commission has approved five biosimilar medicines (human growth hormone and epoetin) under the scientific guidelines and regulatory procedures laid out in the new EU pharmaceutical legislation. A number of additional biosimilar medicines applications are under examination at the European Medicines Agency. In April 2006, Sandoz was the first company to obtain European approval for a biosimilar, the human growth hormone Omnitrope.