On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued an updated joint statement on the interchangeability of biosimilars approved in the EU.
The core was that ‘HMA and EMA consider that once a biosimilar is approved in the EU it is interchangeable, which means the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product’. Interchangeability should only take place after careful consideration of the approved conditions of use. Decisions on how to implement interchangeability are managed by individual Member States and not within the remit of EMA.
The absence of a clear EU-wide position on interchangeability of biosimilars has caused uncertainty among stakeholders, so a harmonized and clear EU-wide position on interchangeability was needed to reduce this uncertainty and ensure prescribers can make informed decisions. Nevertheless, EMA has to date not issued any recommendation on interchangeability.
The EU regulatory network has gained a deep understanding of biosimilars after assessing and monitoring over one hundred biosimilar submissions and their safety on the market. Interchangeability of EU-licensed biosimilars has been confirmed, and approved biosimilars have shown comparable efficacy, safety and immunogenicity to their reference products. Therefore, additional systematic switch studies are not required to support interchangeability.
The Committee for Medicinal Products for Human Use (CHMP) and working parties support that approved biosimilars can be prescribed interchangeably, allowing more patients to access necessary biological medicines. Member States will continue to decide which biological medicines are available for prescribing and whether automatic substitution is allowed.
A previous version of this statement was issued in September 2022 confirming that biosimilar medicines approved in the EU can be used interchangeably with their reference medicine or an equivalent biosimilar. This would allow more patients to access necessary biological medicines for treating diseases like cancer, diabetes, and rheumatic diseases [1].
After releasing the updated joint statement on interchangeability of EU-approved biosimilars, EMA and National Competent Authorities (NCAs) have received inquiries for clarification from healthcare professionals and other members of the public. A questions and answers (Q&A) document had been created to address these follow-up questions.
In the US, an interchangeable product is a biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient [2].
The UK’s Medicines and Healthcare products Regulatory Agency updated its 2021 guidance on biosimilars in November 2022 to allow interchangeability between biosimilars if they use the same reference medicinal product [3].
However, it is important to note that interchangeability in the EU and UK refers to prescriber switching only. This is in contrast with the US where an interchangeable biosimilar can be used in place of an originator and such a switching decision can be made at the pharmacy level [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA calls for biosimilar interchangeability across the EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 12]. Available from: www.gabionline.net/biosimilars/general/ema-calls-for-biosimilar-interchangeability-across-the-eu
2. GaBI Online - Generics and Biosimilars Initiative. Approaches to streamline biosimilar interchangeable programmes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 12]. Available from:
www.gabionline.net/reports/approaches-to-streamline-biosimilar-interchangeable-programmes
3. GaBI Online - Generics and Biosimilars Initiative. UK updates guidance to allow biosimilars interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 12]. Available from:
www.gabionline.net/guidelines/uk-updates-guidance-to-allow-biosimilars-interchangeability
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