A European Perspective on Biosimilars

At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”

While many European health systems would reject the assertion that they had previously restricted the use of biologic treatments, van den Hoven cited several examples of how biosimilars have improved patient care by easing restrictions on biologics: in the United Kingdom, which van den Hoven pointed out is among the wealthiest nations in Europe, granulocyte-colony stimulating factors (G-CSFs) could not be prescribed for prophylaxis of chemotherapy-induced neutropenia under national guidelines because of the high cost of therapy. Once biosimilar filgrastim was available in the European marketplace, treatment with filgrastim “exploded in access” and patients were allowed to receive prophylaxis with G-CSF agents. That change in policy resulted in a 122% increase in filgrastim access in the United Kingdom.

Likewise, in Sweden, 3 physicians were required to sign off on the use of filgrastim for any individual patient prior to the introduction of biosimilars. After market entry, no such sign-offs were required before a patient could receive a G-CSF. In Bulgaria, where patients with rheumatic diseases could not be treated with anti-tumor necrosis factor (anti-TNF) agents prior to biosimilars, the advent of biosimilar anti-TNFs increased patient access by 163%.

Such spikes in access to drugs, said van den Hoven, did not merely represent an increase in the number of prescriptions written for a drug, but an increase in the quality of the overall treatment that patients were receiving.

However, the European experience is not comprised solely of success stories; some European nations have remarkably low biosimilar uptake. Ireland, Belgium, and the Netherlands are among the slowest adopters of biosimilars. “If governments don’t drive biosimilar competition, it doesn’t happen,” said van den Hoven. In looking ahead to the development of the US biosimilars market, van den Hoven suggests that policy makers in the United States can learn from the successes of the European model in several key areas:

Consensus Documents

Among the notable successes of the European approach to biosimilars has been a consensus model of distributing information for providers, patients, and other stakeholders. Under this model, the European Commission and European Medicines Agency publish educational documents produced and disseminated jointly by reference product sponsors and biosimilar developers. The shared approach is designed to promote fairness and agreement among developers and to provide clear and unbiased information.

Benefit-Sharing Models

Another key achievement of the European approach is the benefit-sharing model adopted by some health systems, in which work by healthcare providers to increase use of biosimilars is rewarded by allowing local health systems to reinvest savings in other areas of patient care; van den Hoven cited an example of a health system in the United Kingdom in which cost savings from switching to biosimilar infliximab for the treatment of inflammatory bowel disease was reinvested in hiring a specialist nurse. Where such incentives are lacking, biosimilar uptake is notably absent, however; biosimilar insulins have not been subject to benefit-sharing models, which has limited the use

of biosimilar insulins in practice.

Competition

Procurement models that allow for multiple biosimilars in the market to compete with the reference product are vital, van den Hoven indicated. In Italy, for example, existence of 3 biosimilar options that are all cheaper than the reference product disqualifies the reference from consideration by the nation’s health system. The policy has the effect of encouraging price competition not only among biosimilars, but also with the reference treatment.

Looking ahead, Europe and the United States have the opportunity to engage in a critical, international dialogue about the future of biosimilars and greater international regulatory alignment. For example, van den Hoven says that “FDA guidance on interchangeability creates uncertainty,” and pointed out that, in Europe, no such designation of interchangeability exists. He also indicated that the use of product brand names in Europe (rather than nonproprietary names with suffixes, as in the United States) has led to high product traceability for pharmacovigilance efforts. Finally, he suggested that, in the future, regulatory bodies could consider eliminating the requirement of phase 3 clinical trials for biosimilars in favor of analytical, functional, and comparative data demonstrating biosimilarity as a way to speed the approval availability of biosimilars.