asked Her Majesty’s Government:

What steps they are taking to ensure that, while the Parliamentary Review Health Review report on the introduction of biosimilars into clinical practice outlines precautions to be fulfilled before some such preparations can be approved for clinical use in the United Kingdom, the public and the medical profession can be assured that those biosimilar preparations produced by reputable pharmaceutical companies which have been licensed by the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency can safely be prescribed. [HL4866]

Licensed biosimilar medicines will expand the number of drugs available to patients. Since the complex nature of biological medicines requires careful testing and specialised control of production, it is important that additional factors are taken fully into account when biosimilar medicines are manufactured and assessed. Special European Union regulations are in place to ensure that biosimilar manufacturers supply comprehensive data to demonstrate the quality, safety and efficacy of their product and its similarity to the original reference medicinal product.

All medicines, including biological medicines, should be prescribed by clinicians in accordance with the summary of product characteristics, which provides full information about the product, including its side effects and its use.

All new medicines carry a black triangle symbol when they are first marketed in the United Kingdom. This denotes that the product is under intensive surveillance and this period usually lasts for two years. Biosimilar products are designated black-triangle medicines and carry the black triangle symbol in the British National Formulary. All biosimilar products should also have in place at the time of licensing a full risk management plan that describes what is known about the safety of a product and describes the activities required on behalf of the company to ensure that relevant safety information is collected in the post-marketing period.

The Royal Pharmaceutical Society of Great Britain’s Professional Standards and Guidance for the Sale and Supply of Medicines provides advice to pharmacists on biosimilar medicines and states that, except in an emergency, a specifically named product should not be substituted by any other product without the approval of the patient or carer and the prescriber and, in the case of hospital drugs, the approval of the therapeutics committee, or in line with other similar locally agreed protocols.