BioWorld International Correspondent

BRUSSELS, Belgium - Copies of biotechnology-derived products are likely to need more comprehensive documentation under the new European Union rules on pharmaceuticals.

According to the fine print of the text approved by the European Parliament in late December and due to be adopted by ministers from EU member states in January, preclinical and clinical test data will need to be generated in support of marketing authorization applications for biotechnology-derived and biological products. (See BioWorld International, Dec. 24, 2003.)

Companies will no longer be able to use the procedure frequently employed by generic manufacturers for chemistry-based products, which is to provide no more than a simple mention of the existence of the originator product - or "reference product," as it is termed in the EU.

"Biological medicinal products similar to a reference medicinal product do not usually meet all the conditions to be considered as a generic medicinal product, mainly due to manufacturing process characteristics, raw materials used, molecular characteristics and therapeutic modes of action," the text reads. "When a biological medicinal product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfill the requirements related to safety (preclinical tests) or to efficacy (clinical tests) or to both."

The type and quantity of supplementary data to be provided "must comply with the relevant criteria" set out in the EU rules for authorizing medicines and the related detailed guidelines. "The results of other tests and trials from the reference medicinal product's dossier shall not be provided," the new rules insist.

Those requirements have been greeted as a victory by the research-based European biotechnology and pharmaceutical industry, which feared that too many concessions were being made to generic companies.

Emerging Biopharmaceutical Enterprises - the lobby of smaller European biotech medicine manufacturers - claimed that the provisions were the consequence of the pressure it had been exerting on EU legislators.

"The improved provisions for biosimilars' or follow-on biologicals' are in line with EBE's requests," it said. "This is a significant step forward for EBE companies, and the success is due to the concerted and cooperative hard work of the membership."

At the same time, the text of the new rules will impose a new requirement for authorities to check on the risks a biotechnology-derived product might present for the environment.

"Environmental impact must be assessed and, on a case-by-case basis, specific arrangements to limit it must be envisaged," the rules state. However, the new text does not elevate that requirement to the level of a reason for turning down a request to market a new biotech product. "In any event, this impact should not constitute a criterion for refusal of a marketing authorization," it states.