EAHP Position on Biosimilars Contrasts With US Regulation on Naming, Interchangeability

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines. The paper sets out the EAHP’s position on a number of issues related to biosimilar usage:

• Naming. The EAHP states that a biosimilar product should have the same international nonproprietary name as its reference product, without a suffix, as such a system will help to avoid “confusion over, or undermining of, well-formed regulatory oversight mechanisms for the safety of biosimilar medicines.”
• Extrapolation of indications. The EAHP supports the European Medicines Agency’s current practice of granting extrapolated indications to medicines without requiring new clinical efficacy or safety data.
• Interchangeability, switching, and substitution. The EAHP holds that a reference product and its biosimilar are interchangeable and therefore can be switched. It also holds that biosimilars of the same reference product can be switched with one another. The organization supports substitution at the hospital pharmacy level.
• Information on biosimilars. The EAHP says that the provision of unbiased information to stakeholders is key to enabling appropriate decision making on biosimilar use, and that national medicines information centers should distribute information about biosimilars to stakeholders in national health systems. The group also recommends that providers consult freely with pharmacists in developing and distributing educational resources to stakeholders.
• The role of pharmacists. The EAHP says that hospital pharmacists provide a hub of information concerning the monitoring of outcomes, the real-world use, and the reporting of adverse events related to biosimilars, and that they can provide a useful resource on matters of switching, patient, safety, and quality concerns.

The organization’s position contains marked contrasts to current thinking about biosimilars in the United States. First, the FDA calls for a biosimilar to bear both a nonproprietary name that includes an FDA-designated suffix, devoid of meaning, that will distinguish products from one another. The FDA says that this approach will help to prevent inadvertent substitution of products. It is also considering an approach to suffix formats that will designate interchangeable products.

The FDA’s guidance also differs from EAHP’s position in terms of interchangeability; the FDA’s “Considerations in Demonstrating Interchangeability With a Reference Product” draft guidance indicates that robust data, including switching studies that include at least 3 switches between biosimilar candidates and reference products, will be required before a designation of interchangeability will be granted to a biosimilar product.