This page will bring together all the available PrescQIPP resources relating to biosimilar medicines. This will include resources that cover some of the general principles and issues relating to all biosimilars. Then there will be specific resources that deal with the key biosimilar medicines affecting the NHS currently. Lastly there will be a section dedicated to highlighting some of the most useful websites, publications and reviews that are currently available.
Biosimilar Infliximab (Remsima, Inflectra)
Biosimilar Insulin Glargine (Abasaglar)
General Biosimilar Resources
- GaBI Journal - The Generics and Biosimilars Initiative Journal provides a wide range of articles on all things biosimilar.
- EMA – Medicines Under Evaluation - The European Medicines Agency oversees the regulation of medicines within the EU. This link displays new products, including biosimilars, currently being reviewed. Biosimilars can take between 12-18 months to complete the EMA process.
- EMA – Scientific Guidelines for Biosimilar Medicines - All the relevant guidelines that relate to biosimilar regulation are available here.
- NICE – Evaluating Biosimilar Medicines - This is the updates NICE position statement regarding their position the assessment of biosimilar medicines.
- EGA Handbook - This handbook aims to provide updated information on the current progress of biosimilar medicines in the European Union.
- ABPI Position on Biologic Medicines, including biosimilar medicines - This paper sets out the ABPI position on biologic medicines, including biosimilar medicines.
- Biosimilar Medicines: A National Prescribing Framework - Healthcare Improvement Scotland has led the development of a national prescribing framework to support the safe, effective and consistent use of biosimilar medicines in NHS Scotland.
- European Commission – What You Need to Know About Biosimilar Medicinal Products - A Consensus Information Document - This is a very thorough summary of the key issues with useful Q&A sections for patients and health professionals.
- Biosimilars: The Science of Extrapolation - This is an excellent summary of the most significant issue relating to biosimilars.
- Biosimilars: What Clinicians Should Know - Clinician education is central to implementation of biosimilars. This review summarises all the key issues.
- The What is a Biosimilar Medicine? guide has been produced by NHS England to inform the NHS regarding biosimilars. The document introduces the concept of biosimilars and their discusses their potential place in therapy. Most significantly there are statements regarding switching, substation and interchangeability of biosimilars.