European Generics Association Responds to IAPO Paper on Biosimilars

December 15, 2006
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

Brussels, Belgium (Dec. 5)-The debate over biosimilars in Europe was heightened last week between the European Generics Association and the International Alliance of Patients Organizations, a patient advocacy group that issued a briefing paper on biosimilars to the European Parliament, the legislative arm of the European Union (EU).

Brussels, Belgium (Dec. 5)-The debate over biosimilars in Europe was heightened last week between the European Generics Association (EGA, Brussels, Belgium, www.egagenerics.com) and the International Alliance of Patients Organizations (IAPO, London, www.patientsorganizations.org), a patient advocacy group that issued a briefing paper on biosimilars to the European Parliament (www.europarl.europa.eu), the legislative arm of the European Union (EU).

Earlier this year, the European Commission authorized the first two biosimilars in Europe under the biosimilar pathway of the European Commission. These were “Omnitrope” (somatropin) by Sandoz  (Holzkirchen, Germany, www.sandoz.com) and “Valtropin” (somatropin) by BioPartners GmbH (Baar, Switzerland, www.biopartners.com). Both drugs are used as human growth hormone replacement therapies.

IAPO said the aim of its briefing paper is to equip patient advocates with an understanding of the science and technology of biosimilar medicines to enable them to participate in policy debates. In preparing the briefing paper, IAPO contacted and interviewed stakeholders that included patients’ organizations, regulators, innovator biopharmaceutical companies, biosimilar companies, and hospital organizations to gauge their opinions on the various issues. The report was funded by an unrestricted educational grant from Amgen (Thousand Oaks, CA, www.amgen.com).

“Increasing numbers of biotechnology and biosimilar medicines are becoming available, and we consider it important to help raise awareness of these developments, in collaboration with other stakeholders, so that patients can find the best treatment for them, as an individual, in partnership with their health professionals,” said Albert van der Zeijden, chair of IAPO, in prepared statement. “The EU has led the way, through the work of the European Commission and the EMEA, in developing a regulatory process appropriate for the approval of biosimilars.”

EGA raised concerns over the briefing paper. “The paper falls short of its aim because it demonstrates a basic lack of understanding of the biosimilar concept, at least as applied in Europe. Consequently, by addressing these medicines from a global perspective, it may create misunderstanding among patients and healthcare providers concerning the quality, safety and efficacy, and healthcare benefit of these new medicines in Europe,” said Tim Oldham, chair of EGA’s Biotechnology and Biosimilars Medicines Committeee, in a prepared statement.

EGA said the IAPO paper “particularly fails to highlight that the development of a biosimiilar medicine is specifically targeted to match the reference product in terms of quality, safety, and efficacy.” EGA also said the paper “downplays the stringent European requirements which are defined the in the regulatory framework established in Europe for biosimilar medicines.”