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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Annual STADA Report Shows Record Profit Growth for 2023
March 25th 2024Germany-based biosimilar manufacturer STADA Arzneimittel reports strong financial performance in 2023 with double digit sales growth and billions in profits. The CEO credits the company’s success on their strong company culture and focus for innovation.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.