Does The EU Allow Interchangeable Biosimilars?


The European Union and the United States have slightly different takes on biosimilars and interchangeability. The US sees biosimilars in two distinct forms: follow-on biosimilars that are expected to produce the same clinical result as the reference product, and “interchangeable” biosimilars that can be switched for the reference product.

So far, the FDA has not approved any biosimilars as interchangeable. The FDA released a draft guidance in January on what data needed to be submitted to support an application for an interchangeable biosimilar. When biosimilars are interchangeable, a pharmacist can switch the biologic for its biosimilar without notifying a doctor beforehand.

Even though the EU does not use the interchangeable designation like the US does, officials from the Finnish Medicines Agency, Netherlands’ Medicines Evaluation Board, the Norwegian Medicines Agency, and Germany’s Paul-Ehrlich-Institut all conclude that biosimilars licensed in the EU are interchangeable. The officials wrote an opinion piece in the BioDrugs publication outlining their thoughts on the matter in January.

Although biosimilars are unofficially interchangeable in the EU, there is still the need for interchangeability studies to be conducted. Officially, the region “has no plans to introduce new legal or regulatory requirements for interchangeability studies and thus create two classes of biosimilars.”






Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. In today’s fast-growing, highly regulated generic pharmaceutical market, companies require specialized legal guidance beyond the scope of general corporate and securities counsel. WSGR has an experienced team of experts in key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Learn more at www.wsgr.

About the Author

Related Posts

Leave a Reply