EMA takes a stand against interchangeability, says all approved biosimilars are interchangeable
When AbbVie’s blockbuster rheumatoid arthritis drug finally sees some competition in the US in 2023, there’s likely to be a split field, with some biosimilars, and some interchangeable biosimilars. The added designation allows pharmacists to switch the reference product for the interchangeable without a prescriber’s consent.
And while the US and European drug regulators typically agree on just about everything (with some exceptions), when it comes to this concept of biosimilar interchangeability, the European Medicines Agency made clear in a statement yesterday that all biosimilars approved in the EU are interchangeable with their reference product or with an equivalent biosimilar.
The EMA said it’s making its stance known “because the absence of a clear EU-wide position on interchangeability has been identified as a factor causing uncertainty among stakeholders on the use of biosimilars in clinical practice,” pointing to a study published last year that said, “many prescribers still have doubts on the safety and interchangeability of biosimilars, especially monoclonal antibodies (mAbs) and fusion proteins.”
EMA said it considers a clear EU-wide position on interchangeability necessary “to reduce any uncertainty that prescribers may have when deciding to prescribe biological medicines.”
But the announcement should come as no surprise given the fact that several heads of European regulators in 2017 spelled out this same stance:
Our conclusion is that a switch between comparable versions of the same active substance approved in accordance with EU legislation is not expected to trigger or enhance immunogenicity. On the basis of current knowledge, it is unlikely and very difficult to substantiate that two products, comparable on a population level, would have different safety or efficacy in individual patients upon a switch. Our conclusion is that biosimilars licensed in the EU are interchangeable.
The European concept of interchangeability is also different than in the US, as decisions regarding medicine substitution at the pharmacy level (i.e. the practice of dispensing one medicine instead of another without consulting the prescriber) are managed by individual EU member states, the EMA notes.
The position comes as Europe has gained additional experience in reviewing and approving biosimilars so far, with 86 approvals since 2006, compared with 38 approvals in the US since 2015.
Of those approvals in the US, only three biosimilars have won this interchangeability designation, including one for insulin, Viatris and Biocon’s Semglee; one for AbbVie’s Humira, Boehringer Ingelheim’s Cyltezo; and one for Roche’s Lucentis and Coherus BioSciences’ Cimerli.