Molly Burich: Biosimilar Regulation and Policy in the European Union and the United States

Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses major regulatory and policy differences between the European Union and the United States.


What are some of the major regulatory and policy differences between biosimilars in the US and the EU?

In the European Union, they’ve had biosimilars than the US—they’ve had them in clinical practice for about 11 years. Comparing the two systems is very challenging in a lot of ways, but there are some fundamental differences. A couple of the main differences are that the European Union doesn’t require an additional level or designation of interchangeability to drive automatic substitution. In the US, the FDA requires that, so there will be no automatic substitution unless the interchangeability designation is met. So that’s a pretty significant difference because of the investment required to obtain that designation. There are also changes in naming and labeling. In terms of naming, the European Union determined that there does not need to be a suffix, so no designation because the biosimilars, as they will in the US, have a separate brand name but the generic name or the INN looks the same. Lastly, with labeling, labels in general look very different in the US versus the EU but there’s very little distinction in terms of biosimilar label versus the reference product, in part because the EU has more experience potentially, so there are some key differences. I think the biggest though is interchangeability and I think time will tell as to what that designation means in terms of value to all stakeholders, health plans, physicians, and patients.

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