EMA Publishes New Educational Materials on Biosimilars

On September 13, the European Medicines Agency (EMA) published new, patient-focused materials that aim to make patients aware of biosimilar medicines and how the EMA assures that they are as safe and effective as reference biologics.

The new materials include an animated video, available in 8 European languages, that explains key features of biosimilar medicines. The brief video explains that a biosimilar is not a generic, but that it is highly similar to a reference biologic and has the same mechanism of action. The animation also highlights the increased patient access that biosimilars have facilitated in the European Union by making therapies more affordable for patients. It goes on to outline the EMA’s approach to regulating biosimilars and its postmarketing surveillance activities.

The new video complements the European Commission’s previously released patient-focused question-and-answer document on biosimilars, titled What I Need to Know About Biosimilar Medicines. The document, originally made available in 2017 in 23 European languages, addresses basic information about biologic therapies (What is a biological medicine?) as well as more nuanced questions of policy (Who decides on the availability of biosimilar medicines in particular countries?), and it provides information on how patients can self-report suspected adverse events to the EMA and their local regulatory authorities.

Read more about the European Commission’s patient education efforts on biosimilars.

In tandem with the patient-focused video, the EMA also released new translations of its existing biosimilar guide for healthcare professionals in Dutch, French, German, Italian, Polish, Portuguese, and Spanish. The guide, jointly prepared by the EMA and the European Commission and first made available in English in 2017, provides information on topics including the extrapolation of indications, pharmacovigilance efforts, real-world experience, and the cost-saving benefits of biosimilars.

The newly published materials were presented at the European Commission’s fourth multistakeholder conference on biosimilars, held on September 14 in Brussels, Belgium. The conference brought together patient groups, providers, payers, academics, government officials, and industry to discuss experience with biosimilars across Europe.

Organizations represented at the meeting included the Biosimilar Medicines Group (a member of Medicines for Europe), the European Association of Hospital Pharmacists, the European Cancer Organisation, the European Specialist Nurses Organisation, and others.