EUROPEAN GENERIC GROUP DOWNPLAYS NEW BIOSIMILAR BRIEFING REPORT

A European generic trade group expressed doubts over the validity of a new briefing report released early this week by the International Alliance of Patients' Organizations (IAPO), saying it fails to clearly address the science behind manufacturing a biosimilar, or follow-on biologic.

The European Generic Medicines Association (EGA) said it fears the absence of such information might generate an imbalanced view in the debate over the safety of using biosimilars. "The paper falls short of its aim because it demonstrates a basic lack of scientific understanding of the biosimilar concept, at least as applied in Europe," Tim Oldham, chairman of the EGA's Biotech and Biosimilar Medicines Committee, said.

IAPO presented its "Briefing Paper on Biosimilar Medicines" to patient advocacy groups, pharmaceutical companies and government regulators Dec. 5 in Brussels, Belgium. Part of the group's objective is to get more patients involved in the policymaking process and this latest report "aims to equip patient advocates with an understanding of the science and technology relevant to biosimilar medicines to enable them to participate in policy debates," the alliance said.

But the report, according to the EGA, lacks a clear discussion detailing what scientific considerations, examinations and reviews are essential in the development of biosimilars. For example, it failed to point out that biosimilar development is geared to match the reference product in terms of quality, safety and efficacy using the application of state-of-the-art science and technology, the EGA said. It also downplayed the fact that biosimilars are held to high European requirements based on a strict scientific approach that ensures patient safety.

Information on obtaining the IAPO report can be found at www.patientsorganizations.org/showarticle.pl?id=727&n=37120 (http://www.patientsorganizations.org/showarticle.pl?id=727&n=37120).