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.
Transcript:
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.