BioWorld International Correspondent

BRUSSELS, Belgium - The European Medicines Agency has given a negative opinion on the latest application for authorization as a biotechnology generic - a biosimilar, in European Union jargon. The agency's scientific experts turned down the application from BioPartners, of Germany, for their recombinant human interferon-alfa-2a product, Alpheon, on June 26.

Alpheon, indicated for chronic hepatitis C, has been under review since June 2004. The agency said last week there were major quality concerns and differences identified between Alpheon and the reference product, Roferon-A, in the quality and clinical comparability exercise. The agency said there were "major concerns" regarding the comparability of Alpheon and Roferon-A, including impurities, insufficient data on the stability of the active substance and of the medicine that was going to be marketed, and the inadequate validation of the process for making the finished medicine.

The first-ever EU authorization for a biosimilar was issued earlier this year under a new procedure aimed at facilitating market access for copies of biotech products on which patent cover has expired. The procedure, which provides for abbreviated applications making reference to a similar product already on the market, has been repeatedly attacked by research-based companies, who allege that it poses problems for patient safety.

Austria Loses Battle To Tighten GMO Rules

The outgoing Austrian Presidency of the European Union failed in its bid to win overwhelming support from EU environment ministers to toughen up the controls on genetically modified organisms. A laconic statement issued after last week's environment council noted merely that there had been an exchange of views on developments since the previous council meeting and on further steps. The role of the precautionary principle in the authorization and risk assessment of GMOs and GMO products also was briefly discussed. (See BioWorld International, June 26, 2006.)

But the outcome was that ministers welcomed the measures already decided on to improve risk assessment procedures under the current legislation. The statement also noted "certain delegations underlined the importance of applying the precautionary principle in this context," which is diplomatic language in the EU for a failure to win a majority. The controls on GMOs will, as a result, remain unchanged - for the present at least.

Industry Welcome For European Orphan Drug Scheme

A European Union report on five years' operation of the orphan drugs scheme has been welcomed by the European biotechnology and biopharmaceutical industries. The report, released June 27, confirmed the tangible benefits of the system for patients with rare diseases. It said the scheme also has helped boost growth and jobs in the EU, by stimulating R&D investment for unmet medical need, which in turn has led to new start-up companies.

The joint industry task force of the European Biopharmaceutical Enterprises and of EuropaBio, the European association for bioindustries, said the report will help to increase awareness about rare diseases in the EU and to promote support. So far the scheme has delivered 22 approved therapies in the EU, and the products in the pipeline which have been designated as orphan medicines promise treatments for more than 200 conditions.

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