The European Commission (EC) has launched a patient-focused question-and-answer document, titled “What I Need to Know About Biosimilar Medicines,” in 23 EU languages.
The document contains consensus information on biosimilars that was drafted by representatives from the European Medicines Agency (EMA), the EC, patient groups, prescriber groups, and pharmaceutical industry groups, and is intended to provide patients with unbiased, reliable information on biosimilar therapies. The initiative is a project of the EC’s corporate responsibility program.
The document addresses fundamental questions 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 extrapolation of indications (“Why can a biosimilar medicine be approved for indications for which no clinical studies have been done?”).
The document also provides information on how patients can self-report suspected adverse events to both the EMA and to their respective national regulatory authorities, information on pharmacists’ and physicians’ responsibilities regarding the proper documentation of a patient’s prescribed therapy in patient files, links to information for all biosimilar medicines currently approved in the European Union, and links to advocacy groups for patients who have conditions including rheumatoid arthritis and Crohn’s disease.
Industry stakeholders praised the release of the new document; the European Federation of Pharmaceutical Industries and Associations released a statement congratulating the EC and EMA on the developments made during the program to create the document, saying that the group’s work on this and other documents “contributed significantly to the increased understanding and acceptance of biosimilar medicines.”
Looking ahead to 2018, the EC expects that its biosimilar information guide for healthcare professionals will be available in 6 additional EU languages in the first half of the year. The guide is intended to provide reference information on the scientific and regulatory support for the use of biosimilars in the European Union. The EC is also organizing a stakeholder workshop on biosimilars that will take place in September 2018. The focus of the workshop will be oncology, public procurement, and the role of nurses and pharmacists in spurring biosimilar uptake.