The European Generic Medicines Association has questioned a number of assertions in a briefing paper on biosimilar medicines launched this week in the European Parliament by the International Alliance of Patients’ Associations.

The EGA claims the paper betrays “a basic lack of scientific understanding of the biosimilar concept, at least as applied in Europe.” The generics association is quick to point out that the briefing paper was funded by an unrestricted educational grant from Amgen, the US biotechnology company that markets branded versions of erythropoietin (Epogen, Procrit) and granulocyte-colony stimulating factor (fligrastim, Neupogen) now under threat from biosimilars.

The IAPO paper was presented to an audience of patient organisations, European parliamentarians, biotechnology companies and officials from EU institutions at an event hosted by Dutch Liberal MEP Jules Maaten. IAPO chair Albert van der Zeijden noted the growing number of biotechnology products and biosimilars entering the market and the need to “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.”

The wrong signals?

But the EGA, which was involved in the preparation of the briefing paper, believes it sends out the wrong signals about biosimilars. In particular, it put a question mark over their quality, safety and efficacy, as well as the products’ comparability to reference drugs – a flashpoint between the research-based and generic industries that has so far kept the US Food and Drug Administration from adopting the kind of well-defined regulatory pathway for biosimilars now available in the EU.

Rather than providing a balanced insight into biosimilars as intended, the IAPO paper implied that patients should be seriously concerned about the products’ complexity “merely because they are biosimilars, while omitting to say that these same concerns apply equally to originator biological products,” the EGA said.

The IAPO had failed to highlight that biosimilars were specifically designed to match the reference product in terms of quality, safety and efficacy through the application of “state-of-the-art science and technology,” bolstered by extensive comparability studies, the Association continued. Only regulatory authorities had the expertise and data to judge whether comparability had been shown between a biosimilar and its reference product at all the necessary levels.

One paragraph in the briefing, summarising interviews with patient organisations, stated that biosimilar medicines “should not be seen as always having lower efficacy than the original as some biosimilars may be more effective in certain types of patients,” the EGA noted. As such, the IAPO had managed both to challenge the quality of biosimilars and to claim benefits “that clearly will not be met” by the follow-on products. By Peter Mansell