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On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU are interchangeable with their reference product and other biosimilars of the same reference product.  This means that once approved, a biosimilar can be used instead of its reference product, or vice versa, or replaced with another biosimilar of that same reference product, without the need for additional switching studies.  Decisions on whether substitution can be done at the pharmacy level, without consulting the prescriber, are left up to each member state.

While interchangeable use of biosimilars was previously allowed in the EU, if allowed by the individual member state, this statement is the first recommendation on interchangeability issued by the EMA, with the hope it will reduce uncertainty about the use of biosimilars.  The scientific rationale for this decision is based on monitoring the use and safety of biosimilars for over 15 years, which has shown that biosimilars can successfully be used interchangeably.

The European treatment of biosimilars differs from that of the US, where biosimilars are not considered interchangeable with their reference product unless they have received an interchangeability designation from the FDA.  This requires additional information to show that the biosimilar “can be expected to produce the same clinical result as the reference product in any given patient” 42 U.S.C. § 262(k)(4)(A)(ii) and “for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.”  42 U.S.C. § 262(k)(4)(B).  Usually, the FDA requires a switching study to assess the safety and risks of switching.  However, in some circumstances, a switching study may not be necessary (see First Interchangeable FDA Approval without a Switching Study).

The EMA and HMA’s joint statement can be viewed here.

 


    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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