EU GENERIC FIRMS RESPOND TO "BIOSIMILAR" CRITICISMS

European producers of generic biomedicinesare raising concerns over a controversialnew briefing paper that they sayunfairly disparages the quality and safetyof "biosimilar" medicines. Under the European Union's (EU)terminology, biosimilar medicines are "patent-free, therapeuticallyequivalent biopharmaceuticals produced bycompanies other than originators." The paper, issued by theInternational Alliance of Patients' Organisations (IAPO) inthe European Parliament, was bankrolled through a grantfrom US biotech giant Amgen.

According to officials at the European Generic MedicinesAssociation (EGMA), the briefing paper "implies thatpatients should be seriously concerned about the complexityof these [generic] medicines merely because theyare biosimilars, while omitting to say that these same concernsapply equally to originator biological products." Additionally, the IAPO paper "fails to highlight that thedevelopment of a biosimilar medicine is specifically targetedto match the reference product in terms of quality, safety,and efficacy through the application of state-of-the-artscience and technology," the generic group said.

The EGMA also refuted arguments in the briefing paperthat cost savings of biosimilar medicines are unknown. "Infact, the initial pricing approvals of the EU's first biosimilarmedicine, Omnitrope (somatropin), approved in April 2006,have been from 20% to 30% below that of the originatorproduct," the European generic group said. "A 30% costsavings on biosimilars equates to very large savings forhealth care systems."

As an example, EGMA officials noted that the growingincidence of diabetes will make economically pricedbiosimilar insulin a "vital component of ensuring sustainablehealth care for European patients." The EGMA has calculatedthat the use of just 5 biosimilar medicines wouldgenerate savings of approximately 2 to 3 billion euros ($2.6to 3.9 billion) per year in the EU, they said.