Kaiser Permanente Researchers Review Regulatory Barriers to US Biosimilar Uptake

April 16, 2021

Changes to naming conventions and interchangeability labels are just some of the regulatory barriers standing in the way of biosimilar uptake, according to Kaiser Permanente researchers.

Timothy Chiu, PharmD, is the pharmacist evidence analyst and strategist in oncology
and Catherine Pham, PharmD, MPH, is a pharmacoeconomics and policy fellow at Kaiser Permanente.


What are some regulatory barriers to biosimilar uptake in the United States?

Chiu: So, there are a lot of factors that can contribute to uptake of biosimilars. From the regulatory standpoint, I think that there still are some narratives out there that may lead to some misunderstanding or misinterpretation of the scientific rigor that goes into biosimilar approvals and review.

Narratives are very important. I've seen statements out there that may suggest that the confidence in biosimilar data, even though a conclusion may be that they're noninferior or no clinically meaningful difference to a reference product, or that because a number was a certain way, or the study design was conducted in a certain population, that we wouldn't be able to have the confidence in the biosimilar that we have in the reference product.

I think that's where the complication and the additional rigor to the regulatory review is an opportunity to educate the field and continue to reinforce that we should have confidence in the regulatory review, particularly from the European experience. They've had their report out for a couple years now. Their review and workflow has led to outcomes that have been very exciting and allowed for affordability and access. Those are some of the considerations.

Pham: I think that there have been some regulatory things that have changed over time. With the naming convention, that has changed from when biosimilars were first introduced. I think that causes some confusion for providers and patients alike.

Also, the introduction of the interchangeability designation, I think, has also led to some questions. Does that mean because it's not interchangeable? Does that mean that's not something that we should be using in place of the reference drug? So, I think the more you add nuances, the more opportunity people have questions and concerns about these products.