Published Online: Monday, January 1, 2007

European producers of generic biomedicines are raising concerns over a controversial new briefing paper that they say unfairly disparages the quality and safety of "biosimilar" medicines. Under the European Union's (EU) terminology, biosimilar medicines are "patent-free, therapeutically equivalent biopharmaceuticals produced by companies other than originators." The paper, issued by the International Alliance of Patients' Organisations (IAPO) in the European Parliament, was bankrolled through a grant from US biotech giant Amgen.

According to officials at the European Generic Medicines Association (EGMA), the briefing paper "implies that patients should be seriously concerned about the complexity of these [generic] medicines merely because they are biosimilars, while omitting to say that these same concerns apply equally to originator biological products." Additionally, the IAPO paper "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," the generic group said.

The EGMA 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 (somatropin), approved in April 2006, have been from 20% to 30% below that of the originator product," the European generic group said. "A 30% cost savings on biosimilars equates to very large savings for health care systems."

As an example, EGMA officials noted that the growing incidence of diabetes will make economically priced biosimilar insulin a "vital component of ensuring sustainable health care for European patients." The EGMA has calculated that the use of just 5 biosimilar medicines would generate savings of approximately 2 to 3 billion euros ($2.6 to 3.9 billion) per year in the EU, they said.

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