We need a medical community that is fully educated about the benefits of biosimilars so that the promise of these drugs can be fully realized in the United States.
Biosimilars took center stage this week at the American College of Rheumatology’s (ACR) 2017 Annual Meeting, revealing a growing interest in these drugs among those in the medical community. Yet research presented at the conference revealed that many physicians still lack important information about the safety and efficacy of biosimilars, making it clear that more must be done to educate physicians so that they will prescribe these safe and effective treatments to their patients.
Biosimilar drugs, which have been proven effective in treating patients suffering from chronic and painful conditions such as rheumatoid arthritis (RA), have been available throughout the European Union and other developed countries for more than a decade. Payers, providers, and patients in these countries are increasingly adopting biosimilars because they are proven to be as safe and effective as their biologic reference drugs, and can expand access to care for patients who otherwise may be unable to afford critical treatment.
More than 20 biosimilar medications are now in use across Europe, and none have been withdrawn or suspended for safety or efficacy reasons. The FDA has now approved 7 biosimilars—3 of which are available to patients—and more than 60 are in the pipeline. All of these drugs undergo a rigorous approval process, including a comprehensive review of analytical and clinical studies, to guarantee that they are safe and effective for patients.
This year’s ACR meeting underscores the importance of ensuring physicians are fully educated about biosimilar treatments. One survey presented at the conference found that only 40% of physicians believed biosimilars are as safe and effective as their biologic reference products. Another survey revealed a lack of confidence in the concept of biosimilar extrapolation, as 34% of respondents are not willing to initiate biosimilar treatment unless clinical studies were conducted in the same indication.
Researchers who worked on both surveys concluded that physicians’ lack of knowledge about biosimilars and their ambivalence about prescribing these drugs present a significant barrier for building a robust biosimilars market in the United States.
This barrier has implications not only for patients suffering from RA, but also from psoriatic arthritis, Crohn’s disease, ulcerative colitis, and various types of cancer—including breast cancer, metastatic colorectal cancer, non-squamous non-small cell lung cancer, and glioblastoma.
Recognizing the need for physicians to be better informed about biosimilars, the FDA recently launched an educational campaign to raise awareness about these drugs. Other professional societies, patient advocacy groups, and the Biosimilars Forum also have launched education initiatives. Medical professionals around the country can access these resources to gain substantive insights on biosimilars so that they can discuss biosimilar drugs with their patients.
For example, physicians should become familiar with key terminology—such as biosimilars, interchangeable biologics, and totality of evidence, among others—and take steps to learn about the stringent standards biosimilars must meet for FDA approval. Physicians could also review the FDA’s Purple Book, which is intended to help prescribers stay up to date on which biologic reference products have 1 or more biosimilar products approved by the FDA.
Now that ACR has recognized the potential of biosimilars and the FDA has approved several biosimilar products, physicians have a responsibility to their patients to be well informed about these treatment options. We need a medical community that is fully educated about the benefits of biosimilars so that the promise of these drugs can be fully realized in the United States.