Misinformation Undermines the Perception of Safety and Efficacy of Biosimilars
Biosimilar medicines are a vital part of reducing prescription drug costs to patients, generating about $24 billion in savings since market introduction in 2015.1 Moreover, they increase access to care, as they have facilitated more than 344 million days of patient therapy that would not have occurred without competition from these lower-priced options. However, misinformation campaigns – often driven or silently funded by brand manufacturers – have sought to limit adoption of these U.S. Food and Drug Administration (FDA)-approved products. These campaigns are intended to sow doubt among patients and prescribers regarding biosimilars’ safety and efficacy, and to construct regulatory, policy and legal roadblocks to competition. This helps explain why, as of 2023, the average market share for biosimilars was barely 20 percent.2
This concern was first underscored by former FDA Commissioner Scott Gottlieb during a 2019 interview with the Washington Post. “I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion about the safety and effectiveness of unbranded biologic drugs,” he said. He further noted that the messages “can potentially undermine confidence in biosimilars in ways that are untrue.”
Five years later, the biosimilar industry faces similar challenges, and debunking misinformation remains a top priority for the Biosimilars Council, particularly as it relates to interchangeability and safely switching from brand reference products to FDA-approved biosimilars. Among biosimilars available on the market are those deemed “interchangeable,” which is a specific designation given to some biosimilar products that indicates that they may be substituted for a reference product without the intervention of the prescribing healthcare provider, depending on state pharmacy laws. Unfortunately, confusion around what an “interchangeable” designation means has been exploited by brand companies and other actors to spread misinformation and undermine patient adoption of biosimilars. One of the most frequent unsubstantiated claims made is that switching from a reference product to a biosimilar could be dangerous for patients. Data has proven this false time and time again, and the FDA has been steadfast in emphasizing that switching to biosimilars is safe. In fact, the FDA communicated this in a December 2023 post, stating, “because patients may be switched from a reference product to a biosimilar once it becomes available, FDA would not approve a biosimilar if there were concerns about switching.”
To that end, the Biosimilars Council applauds the FDA for continuing to combat misinformation about biosimilars. In June, the FDA released new draft guidance around promotional labeling and advertising considerations for prescription biological reference products, biosimilar products and interchangeable biosimilar products. The draft guidance emphasizes that it would be false or misleading to suggest that biosimilars are less safe and effective than interchangeable products or than their reference products. It also clarifies that it is appropriate to communicate that a biosimilar may be prescribed to treat patients that are not only new to a therapy but also that are switched from the reference product.
Conclusion
As patients across the country finally begin to reap the benefits of available, lower-cost biosimilars, education around the safety and efficacy of these FDA-approved medicines remains paramount. The Biosimilars Council will continue to promote the facts and dispel the myths to ensure that patients, prescribers, policymakers and all healthcare stakeholders understand the critical role of biosimilars in delivering access and savings.
