BioWorld International Correspondent

BRUSSELS, Belgium - European drug companies are concerned that the latest stage in updating the European Union's rules on pharmaceuticals could leave their biotechnology products open to unfair competition from copy companies.

EU ministers reached agreement among themselves on Sept. 30 concerning the proposed revision of the EU legislation on authorization of medicines - which has been under discussion for more than two years now - and provoked immediate anxiety from the major European pharmaceutical and biotechnology industry associations in Brussels.

Biotechnology industry executives warned that the text adopted by ministers creates a loophole that could allow generic companies to market copies of biotechnology products - what the new legislation terms "biosimilar" products - without adequate testing.

Under EU rules, generic copies of conventional chemistry-based medicines can already obtain marketing authorization through an abridged procedure, using references to existing products rather than performing preclinical testing and clinical trials. EuropaBio, the main EU lobby group for the biotechnology industry, sees a risk of spillover from that procedure, weakening the controls on the new "biosimilar" category. Hugo Schepens, EuropaBio secretary general, called for "more precise language to underline the inherent differences between biotech medicines and medicines based on chemical synthesis."

He said the text needs further modification before it is finalized, to counter this "lack of legal clarity." Basing the argument on public health considerations, Schepens said: "Appropriate preclinical and clinical tests should be obligatory for biosimilar products. This should be clearly outlined in the legislation." The EuropaBio boss stressed the need for "sound legislation, which ensures that only medicines that meet optimal standards should arrive on the market, both guaranteeing patient safety and supporting the future development of the health care biotechnology industry in Europe."

The same point has been stressed by Emerging Biopharmaceutical Enterprises, a group of smaller companies.

"If imprecise definitions are adopted for the standards that copy products must reach, there will be particular risks in the area of biotechnology-derived medicines," it said. "The ministers' text does not make it sufficiently clear that the basis for approval of similar' biological medicinal products should be quality, safety and efficacy, through the performance of appropriate tests," it complained.

"Biopharmaceutical products are very complex," EBE insisted, and "seemingly small differences in their physicochemical nature, or even in their production process, can result in major differences in their biological properties, which can produce major differences in their action and reaction in patients."

And the European Federation of Pharmaceutical Industries and Associations added: "In the interest of public health and in particular assuring patients' safety, further attention must be given to the definition of generics and biological medicines; the latter are becoming increasingly important to provide new breakthroughs in medical research."

The final word will rest with the European Parliament, which is scheduled to complete its examination of the new legislation later this year. EuropaBio said it expects the Parliament to review the biosimilar medicines provisions so as to underline the specificities of biosimilars and their inherent difference to generics.

But the proposed rule changes - which still have to be finally agreed by the European Parliament later this year - did win some praise. EuropaBio conceded that it "may contribute to a stimulation of the health care biotechnology industry in Europe." In particular, it welcomed the extension of the regulatory data protection period - for up to 11 years - for biotechnology-derived medicines.

"This will give companies an incentive to develop new medicines to meet patients' unmet medical needs," Schepens said.

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