In the EU, where biosimilars have been present for over a decade, the definitions of switching, interchangeability and substitution are as follows:
Switching – decision by treating physician to exchange one medicine for another medicine with the same therapeutic intent
Interchangeability – the medical practice of changing one medicine for another that is expected to achieve the same clinical effect in a given clinical setting and in any patient on the initiative, or with the agreement of the prescriber
Substitution – practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber
And while these may seem nuanced, the recent release of draft interchangeability guidance by the US Food and Drug Administration (FDA) has further confused issues, according to Medicines for Europe, an NGO advocacy group for access to generic and biosimilar medicines in the EU.
“The US FDA guidance is essentially a means to obtain a regulatory designation in support of substitution at the pharmacy level, without the involvement of a physician or clinical decision maker,” Julie Maréchal-Jamil, director of Biosimilar Policy & Science, told Biopharma-Reporter.com.
“In the EU, there is no policy supporting pharmacy substitution for biologics.”
European policies
She added the European Medicines Agency (EMA) does not have competence on medical practice and healthcare policies, but instead this is dealt with by national competent authorities in each individual member state.
“Europe is fully harmonised on the fact that EU authorised biosimilar medicines are considered alternative therapeutic options to their respective reference product, under the supervision of a clinical decision maker,” she continued.
However, “When it comes to medical practice and healthcare policies, each member state is to decide on the policy framework guiding the use of biosimilar medicines.”
As such, regulators from some – but not all – European countries have posted positioning statements on physican-led switching for biosimilar medicines. Check out our infographic below as to the latest regulatory opinions: