BioWorld International Correspondent
BRUSSELS, Belgium - The European Union market for biotechnology-derived medicines has come under generic competition for the first time.
April 19, the EU authorities authorized Sandoz's recombinant somatropin, called Omnitrope. The application was based largely on documentation for Pfizer's version of the product, Genotropin, which has been on the EU market since 1988 and now is out of patent protection there.
It is the first authorization for what the EU terms "biosimilars" - generic versions of biotechnology-derived medicines. A new procedure has been created by the EU authorities to cope with the expected flood of biotech copies as the first patents start to expire.
The European Medicines Agency evaluated the application and gave a positive scientific opinion in January: Studies with Omnitrope had shown comparable quality, safety and efficacy to the reference product, it decided. That opinion now has received official EU endorsement.
The EU is fully supportive of the development, since "biosimilar alternatives are less costly while being safe and efficient like the 'original' biotech drugs," said European Commission Vice President Günter Verheugen. "Biosimilar medicines offer new opportunities, both for the growth of our generic industry and for the control of national health care expenditure," he said.
However, Verheugen stressed the additional safety dimension of biotech copies.
"These complex products must comply with the same rigorous standards for quality, safety and efficacy as for any other medicine, for the benefit of European patients," he said.
The EU authorities insist that "unlike standard generics," biosimilars "are usually complex biological molecules claimed to be similar - but not identical - to already authorized biotechnology medicines. They therefore cannot be regarded and regulated as generics." Instead, they are "like other biotech medicines, not easy to produce and sensitive to manufacturing changes."
The EU decision was welcomed by the European Generic Medicines Association, which has been campaigning vigorously for easier access to the market for biotech copy products. Its director general, Greg Perry, forecast that the "EU will now develop into the global center for the research and development of biosimilar medicines."
The generic industry is continuing to lobby to win the right for biosimilar medicines to carry the same INN when they have proven equivalence to the reference product - a move that biotech medicine originators are seeking to prevent.
Renewed Industry Concern On EU GMO Prejudice
What is seen as anti-biotech bias among senior European Union officials is causing anxiety to the European biotechnology industry. A closed-door discussion within the European Commission during April has led to proposals to tighten up the legislative framework for GMOs.
Two key members of the commission with well-known reservations about biotech - Cypriot Markos Kyprianou, responsible for health and consumer protection, and Greek Stavros Dimas, responsible for environment - persuaded the commission to pay less attention to safety clearances granted by the European Food Safety Agency, and more attention to doubts expressed by member states.
The commission has in consequence stated that it will go to greater lengths to "reassure member states, stakeholders and the general public" about protection of human health and the environment in EU decisions on GMOs. While the formal announcement refers merely to efforts to "improve the scientific consistency and transparency" of decisions and "develop consensus between all interested parties," the move is seen as a setback for independent scientific judgement, and as a slap in the face to the two commissioners who argued against the changes - German Günter Verheugen, responsible for industry affairs, and Slovene Janez Potocnik, responsible for science and research.
The tougher attitude toward biotech has provoked industry protests to European Commission President Jose Manuel Barroso. EuropaBio wrote to express its concern over "the continued delay in the proper implementation of the EU's regulatory approval process for the products of agricultural biotechnology." Currently, the approval process already is "unpredictable and unreliable" for biotech companies, it said, and it is deeply worried at suggestions that positive safety assessments from the EU's independent scientific body may be set aside if member states still have doubts over a product's safety.
EuropaBio says the opposition of inveterate opponents of biotech among the member states "is clearly not science based, but is political - a most unsatisfactory situation." But environmental activists welcomed the commission announcement. Friends of the Earth Europe greeted the proposal as a step in the right direction, accusing EU authorities of siding for too long with the biotech industry, and ignoring any research or opinions that questioned safety.
"The commission should now suspend all new approvals until public and environmental safety can be guaranteed," demanded its GM campaign coordinator, Adrian Bebb.
April 18, Friends of the Earth released documents allegedly prepared by the European Commission that admit to serious doubts over the health and environmental impacts of GMOs. The environmental group claims the commission documents concede that on human safety, "there simply is no way of ascertaining whether the introduction of GM products has had any other effect on human health"