FDA’s Tacit Encouragement of Interchangeability of Biosimilars
[Posted on: Thursday, October 26, 2017]
This week FDA released several new pages on its website to “better inform physicians about biosimilars through education about these potentially cost-saving options”, tacitly encouraging physicians to prescribe biosimilars over the innovator biologics. The interchangeability of biosimilar versions of biologics with the reference drug is a hotly contested milestone by the developers of biosimilar products. Under the current rules, it is very hard to prove interchangeability of biosimilars approved by FDA and their corresponding reference biologics. This new initiative is designed to educate the physicians that biosimilar versions of a biologic are essentially identical to the reference biologic in their clinical applications and encourages physicians to consider biosimilar version over innovator biologics to save cost to the patients. Using several graphics, comparison charts, and other educational material, FDA is essentially saying that biosimilar are interchangeable without using the word “interchangeable”. There is definitely need to educate physicians about biosimilars. Surveys have shown that physicians are reluctant to prescribe biosimilars, and laws prohibit interchangeability unless a biosimilar is explicated labeled as such by FDA. This new initiative is shot in the arms of the biosimilar advocates who would like to see interchangeability just like there exists for generic drugs. Adding FDA’s highly credible voice to this argument will go a long way to convince physicians to prescribe biosimilars. The concern is that undercutting its own rules about establishing interchangeability of biosimilars and the corresponding reference biologic, could discourage biosimilar developers to do the extra work needed to prove as such. A biosimilar manufacturer can simply cite FDA’s own words to market their products to physicians as essentially interchangeable products. FDA has previously expressed concerns about the interchangeability of biosimilars. This new initiative somewhat contradicts it. This announcement reflects that FDA management is getting impatient with the delay in proving interchangeability. It’s a tacit acknowledgement that FDA believes formally interchangeable biosimilars have ways to go. But this may be a potentially slippery slope. FDA has to deal with the regulatory conundrum of trying to do its job of enforcing the law and trying to meet its mission of increasing accessibility of therapeutics. This is a good case study of this challenge. We will keep an eye on this evolving situation.