The FDA vs the EC: Two Very Different Ways to Address Biosimilar Education

The new patient guide on biosimilar medicines issued by the European Commission (EC), “What I Need to Know About Biosimilar Medicines: Information for Patients,” highlights the very different ways the EC and the FDA approach educating the public about biosimilar medicines.

The EC educational guide emphasizes that it has been created by and for patients, with input from the European Medicines Agency (EMA) and EC, and seeks to reassure the public about biosimilar medicines by stressing the EMA’s careful regulation of this developing market. In the United States, by contrast, it is estimated that nearly 70% of consumers don’t know what a biosimilar is, and there also appears to be a significant amount of confusion among US experts about biosimilars. Yet, the FDA is not adequately reaching out to US patients with the kind of guidance its European counterpart is.

While it is true that the EU did get a head start in the biosimilar category—its first biosimilar was approved in 2006 and there are now some 2 dozen biosimilars approved for use compared with the FDA’s 4 biosimilar approvals—the FDA needs to invest more in educating patients and their physicians on biosimilars. One of the offerings of the FDA is a continuing education course for healthcare providers, but more needs to be done as we will soon see a steady stream of biosimilars entering the market. Although the FDA has made strides in the last year with setting scientific standards for biosimilars and is additionally working with the pharmaceutical industry to develop a regulatory framework, efforts also need to be directed to help shape consumer attitudes toward adoption of this new class of drugs.

The EC guide exploits a user-friendly Q-and-A format and simple examples to illustrate complicated ideas. The guide starts with the history of biosimilars and explains in easy-to-understand language what patients need to know about the biological drugs that biosimilars are based on. It discusses what it means to be “highly similar” to an existing biological medicine that has already been approved. Furthermore, the guide specifies why biosimilars are not the same as generic drugs, and explains why biosimilars have been developed and how they are approved. Above all, the guide reassures patients that “biosimilars are not simply ‘cheap copies’ of reference medicines” and are manufactured following strict quality requirements using state-of-the-art methods subject to strict inspections—similar to other drug manufacturers. Although the EMA evaluates biosimilars using a different set of data compared with other biological medicines, the same high standards of quality, safety, and efficacy apply.

Most important, the EC patient guide stresses individuals’ empowerment, advocating that patients on biosimilars should work closely with their physicians and pharmacists and that they report any adverse events experienced with these drugs.