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.
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