.png)
Agenzia Italiana del Farmaco
Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU - Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU
Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU
EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
While interchangeable use of biosimilars is already practiced in many Member States, this joint position harmonises the EU approach. It brings more clarity for healthcare professionals and thus helps more patients to have access to biological medicines across the EU.
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Interchangeability in this context means that the reference medicine can be substituted by a biosimilar without a patient experiencing any changes in the clinical effect.
In "Related documents" the press release and the EMA-HMA joint statement
Published on: 21 September 2022
Contacts
Via del Tritone, 181 00187 Roma
VAT number: 08703841000
Tax code: 97345810580
IPA AIFA code: aifa_rm
IPA UCB code: UFE1TR