BioWorld International Correspondent

BRUSSELS, Belgium - The European biotechnology industry is increasing its pressure on international regulators to defend their innovations against what they see as unfair copying. A large delegation from the innovative industry took part in a Nov. 13 meeting in Geneva, where the World Health Organization led talks on naming conventions for biotechnology-derived medicinal products, including biosimilars.

Innovator companies are arguing that the current system for international non-proprietary names (INN) needs improving to avert risks of confusion between biotech products and generic copies of them - "biosimilars," as they are termed in Europe. Developments over the last five years call for the WHO to update the system, to reduce the risk of inconsistencies in naming conventions for biotech products. The WHO should adapt its nomenclature for biologicals to reflect the state of science, said European Biopharmaceutical Enterprises, one of the industry associations that took part in the meeting.

At issue is whether biosimilars should be systematically entitled to carry the INN of the originator product - a move opposed by innovators, but supported by generic companies. Innovators fear that possible differences between originator and copy product may be blurred if copies have an automatic right to the same INN.

A distinct INN for each biotech medicine or biosimilar also would make it easier to trace adverse events, and would limit the scope for inappropriate automatic substitution of biosimilars for originator products. The research-based industry has been arguing with increasing energy that inadequately controlled introduction of biosimilars generates safety concerns.

Following discussion at the meeting on whether biologics produced by different manufacturers should be given the same or a distinct INN as the innovator product, the WHO committee on INNs now is reflecting on whether to make new proposals for taking into account those views.

The industry said that a future review of the INN system for biologicals, including biosimilars, should seek to ensure consistency while looking ahead, and should deal better with the complexity of biologicals and biotech medicines and the fast pace of change in the sector. "This expected outcome would be positive for the innovator industry," said Carlo Incerti, EBE president, after the meeting.

It was the first WHO meeting on the naming of biologicals and biotechnology products, including biosimilars. It comes five months after the European Medicines Agency's guidelines on biosimilars came into effect. EuropaBio, the European biotech industry association, said fundamental issues still remain unclear on naming and labeling requirements for biosimilars.

A unique INN for each medicine in the EU will help provide precise pharmacovigilance information: "Multiple biosimilar products of a certain innovator product on the market without a proper identification system could lead to inadequate reporting of safety events that could be wrongly attributed to a particular manufacturer. This could lead to a dilution of messages about safety," EuropaBio warned.

In addition, the nature of biosimilar medicines - which are categorized as "similar, but not identical" - means that substitution for the innovator product could have clinical consequences in which patients respond differently to the two products. "Clear identification of biosimilar medicines could provide a safe mechanism for ensuring the patient is dispensed the precise medicine prescribed by the physician," EuropaBio said.

Germany Plans EU Biotech Conference

Germany, which takes over the chair of EU business for six months on Jan. 1, is planning a major biotech conference in Cologne on May 31, as a key part of its just-revealed program to boost the competitiveness of European business. The intention is to agree to a "Cologne Declaration" to give a major political boost to building the bio-based economy in Europe. Already a working group on framework conditions for European bioindustries is being set up, including European biotech industry representatives, to prepare the Cologne Declaration.

European Medicines Agency Gets New Appointment

Professor Hans-Georg Eichler was appointed as the first senior medical officer of the European Medicines Agency. The agency said the creation of the post is intended to consolidate the agency's increased scientific role following recent changes in EU pharmaceutical legislation, and underlines the commitment to enhance the scientific competence of the agency. Eichler, who will take up his post in February 2007, is professor of clinical pharmacology at the Medical University of Vienna, and a member of the Scientific Advice Working Party of the agency's committee on human medicines.