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Industry groups are calling for clear FDA guidance on language used by biologic originators to protect market share.
Time and time again, across industry articles and reports, you’ll see a similar theme: the U.S. biosimilar market has not developed as quickly as expected. While there are many reasons for the lag in adoption, many suggest that patients and providers-despite the FDA’s education efforts-remain skeptical of biosimilars.
Some companies are going so far as to blame the information provided by innovator manufacturers in “inappropriate communications” for some of that skepticism. In fact, last August, Pfizer filed a citizen petition requesting that the FDA provide new guidance on what they called “misleading representations and suggestions by reference product sponsors” by companies like Amgen and Genentech. They allege that such communications imply that biosimilars are neither as safe or as effective as their biologic predecessors-and they hope the FDA will offer official clarification to staunch such deception language in marketing collateral.
“What this petition is about is increasing the availability of accurate information, as well as dispelling misinformation about biosimilar agents,” says Christine Simmon, senior vice president of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association. “What we’re seeing is that a lot of the innovator manufacturers are going to great lengths to protect their monopolies on market share and thwart competition-and Pfizer is seeking action against those that would purposefully engage in misinformation campaigns that undermine patients’ and providers’ understanding of the safety and efficacy of biosimilars.”
In the months since, other companies (including Novartis) have made public statements supporting the Pfizer petition-and several industry groups, including AAM, have joined the fray as well. According to Simmon, her organization says terms that many innovator manufacturers are using in their marketing materials like “non-medical switching” are deliberately misleading-and may scare providers and patients away from using equally effective but less expensive treatment drugs.
“Biosimilars are FDA approved. They are safe. They are effective,” she says. “When transitioning from a referenced product, patients should understand that these drugs work. When pharmaceutical companies use terms like ‘non-medical switching,’ they make it seem like a patient is being asked to do an entirely different treatment based solely on cost considerations, not use a drug that has been deemed to have no clinically meaningful differences from the biologic product.”
She also mentioned that confusion regarding “interchangeability,” and what that really means, is also problematic.
“Eventually, a biosimilar will achieve the ‘interchangeable’ designation. But they will get that not because there’s something better about that drug. They will get that designation because the biosimilar manufacturer went through and added some critical process that required a lot more time and money,” she explains. “Interchangeability is not a quality attribute. And we don’t see this designation anywhere else in the world because, frankly, biosimilars are already interchangeable just by the nature of being FDA approved.”
Simmon, as well as the others involved with this action, hope to see the FDA issue clear guidance on what innovator manufacturers can and can’t say about biosimilar competitors. She is calling upon the agency to create an action plan that can help expand market access and foster real competition between biologics and their biosimilar counterparts.
“The FDA itself has expressed concerns about misinformation campaigns and they’ve been a real champion for biosimilar products,” Simmon says. “There is no reason to cast a weary eye on these FDA approved products. We’ve seen that biosimilars are successful in Europe, so it’s important for key stakeholders to become educated about the realities of biosimilars so they can start utilizing them, offering patients greater access to more affordable treatments.”
Kayt Sukel is a science and health writer based outside Houston.