The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its 2021 guidance on biosimilars [1] in November 2022 to allow interchangeability between biosimilars if they use the same reference medicinal product (RP).
The UK’s guidance is designed to provide developers of biosimilar products with a clear outline of the requirements in the country. In addition, the MHRA advises that applicants should consider the guidelines from the Committee for Medicinal Products for Human Use (CHMP), as well as local laws.
The 2021 guidance has now been updated to include the following information on interchangeability:
Once authorized, a biosimilar product is considered to be interchangeable with their RP, which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect. Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP.
As a result of interchangeability, switching patients from one product to another (RP or biosimilar) has become clinical practice. The decision rests with the prescriber in consultation with the patient, in line with the principles of shared decision making; both need to be aware of the brand name of the product received.
All biological medicines, including biosimilars, should be prescribed by brand name.
Here, the RP must already be licensed in the UK or in the EU via the centralized, decentralized, or mutual recognition procedures between the EU and the UK. If an RP is licensed in another region, additional clinical information or bridging studies may be required/requested.
In September 2022, the European Medicines Agency (EMA) announced a similar decision regarding the interchangeability of biosimilars and their RPs [2]. Following Brexit, the MHRA produced new guidance for biosimilars [3] and this has received some updates which are divergent from European guidelines [4].
It is important to note here that interchangeability in the UK and EU refers to prescriber switching only. This is in contrast to in 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 [5, 6].
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References
1. GOV.UK. Guidance on the licensing of biosimilar products [homepage on the Internet]. [cited 2023 Jan 13]. Available from: https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products
2. 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 Jan 13]. Available from:
www.gabionline.net/biosimilars/general/ema-calls-for-biosimilar-interchangeability-across-the-eu
3. GaBI Online - Generics and Biosimilars Initiative. UK releases post-Brexit biosimilar guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from: www.gabionline.net/guidelines/UK-releases-post-Brexit-biosimilar-guidelines
4. GaBI Online - Generics and Biosimilars Initiative. UK’s MHRA updates its guidance on licensing biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from: www.gabionline.net/guidelines/uk-s-mhra-updates-its-guidance-on-licensing-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Approaches to streamline biosimilar interchangeable programmes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from:
www.gabionline.net/reports/approaches-to-streamline-biosimilar-interchangeable-programmes
6. GaBI Online - Generics and Biosimilars Initiative. What does the designation of interchangeability for biosimilars in the US mean [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from:
www.gabionline.net/biosimilars/research/what-does-the-designation-of-interchangeability-for-biosimilars-in-the-us-mean
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