EGA Press Release

Tuesday, 5 December 2006

IAPO PAPER IGNORES THE SCIENCE OF BIOSIMILARS

European producers of biosimilar medicines (ie, patent-free, therapeutically equivalent biopharmaceuticals produced by companies other than originators) have raised doubts over the reliability of a briefing paper on biosimilars launched today by the International Alliance of Patients’ Organisations (IAPO) in the European Parliament. The briefing paper was funded by an unrestricted educational grant from the US biotech company, Amgen.

The paper is intended to provide patients worldwide with a balanced insight into biosimilar medicines. While welcoming the IAPO initiative, Dr Tim Oldham, Chair of the EGA’s Biotechnology and Biosimilar Medicines Committee, commented:

“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. Consequently, by addressing these medicines from a global perspective it may create misunderstandings among patients and healthcare providers concerning the quality, safety, efficacy and healthcare benefit of these new medicines in Europe.”

This lack of understanding both exemplifies the need for briefing papers such as this, but also the need to ensure scientific rigour even in papers designed for lay audiences.

In general the paper implies that patients should be seriously concerned about the complexity of these medicines merely because they are biosimilars while omitting to say that these same concerns apply equally to originator biological products.

The paper particularly fails to highlight that the development of a biosimilar medicine is specifically targeted to match the reference product in terms of quality, safety and efficacy through the application of state-of-the-art science and technology.

Extensive comparability studies must be submitted to the regulatory authorities who alone have the expertise and the data to judge whether comparability at the level of quality, safety and efficacy has been demonstrated between a biosimilar and its reference product. The IAPO paper, however, invites patient organizations to address these issues. This approach reflects a regrettable lack of confidence in the EU regulatory authorities.

It also downplays the stringent European requirements which are defined in the regulatory framework established in Europe for biosimilar medicines. These rules are based on a strict scientific approach, which insures the highest standard of patient safety.

In a particularly telling paragraph summarizing interviews with patient organisations, the IAPO paper both challenges the quality of biosimilar medicines and claims benefits that clearly will not be met by biosimilars, saying that “Biosimilars should not be seen as always having lower efficacy than the original as some biosimilars may be more effective in certain types of patients” (page 33). According to Dr Oldham,

“If you can’t demonstrate comparability, your product won’t be authorized as a biosimilar. Our industry has always supported this approach. In the EU, ‘biosimilar’ is a mark of security for patients.”

Regarding the naming, labelling and traceability of medicines, it is important to clarify that biosimilar medicines in Europe cannot be marketed under the INN (International Non-proprietary Name) alone, but must be accompanied by the company name or a brand name, thus providing the same identification of products as for branded originators.

Suzette Kox, Senior Regulatory and Scientific Director of the EGA, participating yesterday at an IAPO workshop on biosimilar medicines, which was funded by an unrestricted educational grant from Janssen-Cilag, a Johnson & Johnson company, also refuted arguments in the briefing paper that cost savings of biosimilar medicines are unknown. In fact the initial pricing approvals of the EU’s first biosimilar medicine, Omnitrope®, approved in April 2006, have been from 20% to 30% below that of the originator product. A 30% cost savings on biosimilars equate to very large savings for healthcare systems which can be transferred to providing additional access to treatment for patients.

This is a critically important fact. For example, the growing rate of diabetes will make economically priced biosimilar insulin a vital component of ensuring sustainable healthcare for European patients. The EGA has that calculated the use of just five biosimilar medicines would generate savings of approximately €2-3 billion per year in the EU which can be reallocated for wider treatment of the respective disease or to finance medicinal treatment for patients suffering from other chronic disease.

“For the EGA, patient safety and patient access is paramount and we will work together with patient groups, healthcare professionals and governments to ensure that critically important medicines are made available to the widest number of patients possible in the European Union”, said Dr Oldham.

Further information on biosimilar medicines

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