EMA Clarifies Its Policy on Biosimilar Interchangeability

The European Medicines Agency’s (EMA) policy on interchangeability of biosimilars relates only to the active substance and formulated product, the agency said in a clarifying statement.

Referring to an EMA policy statement issued last fall about biosimilar interchangeability, the agency moted that the statement “does not include potential issues related to the handling of different administration devices,” such as the need for patient training when using a new device, or “physician or patient perception of biosimilars.”

“As for any biological medicinal product, traceability should also be ensured for biosimilars to allow for proper root cause analyses in case adverse drug reactions occur,” the clarifying statement said.

Even complex molecules can be safely switched, the statement noted.

“The comprehensive comparability exercise required for establishing biosimilarity makes negative consequences of switching highly unlikely,” the agency wrote. “Such practice is already taking place in some EU member states without any signs of change in efficacy or safety for the patients.”

However, the EMA advised practitioners to consult the prescribing laws and clinical guidelines issued in their own countries before initiating a switch.

“These matters fall under national remit and are issued by the relevant bodies in each Member State,” the agency said. “The statement is meant to advise those Member States that want to allow for biosimilar prescribing, including any national decision on switching and/or automatic substitution. However, each Member State will decide on how this is applied in their territories.”