Following a consultation in 2020, the UK MHRA has published detailed guidance on the licensing of biosimilar products.
Who is the guidance for?
The purpose of the guidance is to provide developers of similar biological medicinal products (aka biosimilars) with a clear outline of the requirements for biosimilar products in Northern Ireland/Great Britain/UK.
Under what headings is information provided in the guidance?
The guidance is provided under the following headings:
- Introduction
- General principles
- Content of a biosimilar application – This is split into the following sections:
- Quality
- Non-clinical,
- Clinical,
- Product labelling
- Risk Management Plan
- Traceability – In the post-authorisation period, as a result of manufacturing, product variability over time within and across products with similar active substances is possible. Therefore, a key requirement for pharmacovigilance of biosimilars is the need to ensure continuous product and batch traceability in clinical use to support detection of any important safety issues that may be product or batch specific.
- Interchangeability -Once authorised, a biosimilar product is considered to be interchangeable with their Reference Product (RP), which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect. The decision to switch 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.
- Substitution -Substitution at the pharmacy level without consulting the prescriber is not permitted for biological medicines, including biosimilars
- Further information
Source: MHRA website