Association of European Cancer Leagues Calls for Faster Biosimilar Uptake

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

The white paper begins on a sobering note, highlighting the fact that substantial disparities exist in patient access to cancer therapies among European nations; many biologics available in Western European countries are not available, or not reimbursed, in Eastern Europe, and even within individual nations, access to drugs can vary widely by region. The ever-rising cost of therapies is a primary driver of these disparities, say the authors.

One factor keeping prices high is the landscape of intellectual property protections that, while less challenging than in the United States, still contributes to an uncertain market for biosimilars. In the European context, Supplementary Protection Certificates (SPCs), which grant 5 added years of patent protection to drugs, are one key blockade to biosimilar market entry.

Read more about SPCs.

Post-launch, however, uptake of anticancer biosimilars has been relatively slow, and that fact, argues the paper, is one reason that the cost of cancer treatment remains high. The authors point to differences in pricing and reimbursement policies across different nations as a key issues hampering uptake, but they indicate that the main hurdle for biosimilars is a lack of knowledge and education among key stakeholders—especially providers and patients—which effectively blocks informed decision-making about using these drugs.

The white paper calls for “precise and reliable information from independent institutions and better communication and education on the use of biosimilars” as a way to overcome this obstacle to cost savings. It also calls for support for substitution and switching programs on an EU-wide level.

The white paper’s authors make 5 specific recommendations to encourage biosimilar use after authorization. First, question-and-answer documents and knowledge-sharing platforms on biosimilars must be developed. Second, quotas or gain-sharing policies must be implemented related to physicians’ prescribing practices. Third, the European Medicines Agency should develop guidelines for switching, and such guidance should be published in a biosimilar’s European public assessment report summary and in its product label. Fourth, switching programs should be supported by payers and industry, and biosimilar use should be discussed in clinical prescribing guidelines. Fifth, national and European medical societies should offer guidance and trainings for their members, and patient organizations should also raise awareness among their members, according to the paper.