Licensing of biosimilars in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance covering the licensing of biological medicinal products (biosimilars) in the United Kingdom (UK).

A biosimilar is a biological medicinal product with a version of the active substance found in an already authorised original biological medicinal product, known as the reference product (RP).  Establishing the similarity between the biosimilar and the RP forms the core of an application, with the guidance detailing the relevant information that needs to be provided by an applicant. The MHRA guidance document is based on the relevant Committee for Medicinal Products for Human Use (CHMP) guidelines along with the Human Medicines Regulations.

The bulk of the guidance is formed of comprehensive sections detailing the content that needs to be included in specific modules of a biosimilar application, covered by the following headings:

  • Quality
  • Non-clinical
  • Clinical
  • Product labelling
  • Risk management plan

Traceability of a biosimilar is another important requirement, stipulating 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. This pharmacovigilance activity should be fully integrated in the healthcare setting (through electronic data recording and record linkage for example).

Another key concept detailed in the guidance is interchangeability. Once authorised, a biosimilar is considered interchangeable with its RP whereby the prescriber can choose between either of the two and expect to achieve the same therapeutic effect. It has become clinical practice to switch patients from one product to another but only after consultation with the patient. In the interest of patient/prescriber awareness, all biological medicines, including biosimilars, should be prescribed by brand name. However, it is important to note that at the pharmacy level, substitution of biological medicines (including biosimilars) is not permitted without first consulting the prescriber.

The full guidance document can be found here.