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.
B111 – Biosimilars: An Introduction
For most people the issue of biosimilar medicines is a new one. Although the medicines involved may be very familiar there are a host of questions raised for those considering using biosimilar versions of the existing products. This document seeks to provide some clarity of many of the common issues raised for anyone new to this area.
Preparing for Biosimilars Webinar (Primary Care)
First this webinar aimed to explain what biological and biosimilar medicines are and how they are manufactured. Then it sought to describe the opportunities that they will create for more cost-effective prescribing and how best to make the most of these new medicines
Preparing for Biosimilars Webinar (Secondary Care)
Prescribing of biological medicines, and therefore biosimilars, will often be initiated within secondary care. Therefore it is vital that these prescribers also understand the key issues as well as the potential for effective use of resources that these medicines offer.
Biosimilars Event 2015
On the 8th May PrescQIPP hosted an all-day event centred on the biosimilar of infliximab. The aim was to bring clinicians, nurses and pharmacists together to discuss the key issues relating to the implementation and uptake of the biosimilar in clinical practice. Initial presentations focussed on the science of biologics and biosimilars for those unfamiliar with the technical aspects underpinning these drugs and how they are regulated. Following on from this were two sessions that aimed to explain the commissioners viewpoint and the key issues from the patients’ perspective. Some of the latest data relating to real-world usage in gastroenterology patients was discussed after lunch. Next PrescQIPP’s secondary care lead, James Kent, attempted to demystify some of the more contentious issues relating to biosimilars. Lastly there were two presentations from clinicians based in rheumatology and gastroenterology. Both of these talks highlighted the key issues within these two specialities and possible approaches to encourage usage going forward. In particular the talk by Dr Fraser Cummings, from Southampton, illustrated what is possible when commissioners and providers work together to maximise outcomes for patients and the local health economy. All NHS employees registered on the site can now access the presentations below.
Biosimilar Infliximab (Remsima, Inflectra)
B111 – Infliximab Summary for Commissioners
Biosimilar infliximab is the most significant biosimilar to become available within the NHS for many years. Primary care commissioners / Pharmacy Leads need to be able to understand the particular issues that relate to the biosimilar version of infliximab as well as the key issues affecting uptake.
B111 – Infliximab Summary for Prescribers
The prescribers of infliximab (gastroenterologists, rheumatologist and dermatologists) will not be familiar with biosimilar medicines. This document discusses the main areas of concern for prescribers such as the EMA licensing process, indication extrapolation as well as which patients should be considered for the biosimilar.
Infliximab Switch - Patient Letter
One of the difficult areas for prescribers will be explaining biosimilars to their patients. This area is unavoidably complex and levels of patient understanding will vary widely. This letter is completely adaptable to local needs but seeks to get many of the key issues across as succinctly as possible.
Biosimilar Insulin Glargine (Abasaglar)
B130 - Biosimilars Insulin Analogue – Bulletin
B130 - Biosimilars Insulin Analogue – Briefing
B130 - Biosimilars Insulin Analogue – Issues and Concerns
Biosimilars - An Update - Webinar
In this webinar from the 13th November 2015, PrescQIPP's Secondary Care Lead, James Kent provided an update on Biosimilars with a specific focus on Insulin Gargine.
B154 - Biosimilars Etanercept – Bulletin
This resource discusses the key issues for healthcare professionals considering a switch to biosimilar etanercept and also provides patient resources to support change.
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.
Biosimilar Infliximab Resources
- EMA – Remsima and EMA – Inflectra - The EMA produce a European Public Assessment Report (EPAR) for every medicine they oversee and regulate. These two links take you to the designated page for the following products where the EPAR, and other documents, can be found.
- NICE - Introducing Biosimilar Versions of Infliximab: Inflectra and Remsima - This resource has been developed to provide practical information and advice on the use of biosimilar versions of infliximab.
- The Challenge of Indication Extrapolation for Infliximab Biosimilars - This is a useful summary of the issue of extrapolation in particular how it relates to infliximab biosimilars.
- HSJ Commissioning Supplement - This supplement to the HSJ contains some useful testimonies and real-world examples of biosimilar adoption.
Biosimilar Insulin Glargine Resources
- EMA – Abasaglar - Here is the link to the Abasaglar section on the EMA website.
- Production and Manufacturing of Biosimilar Insulins: Implications for Patients, Physicians, and Health Care Systems - A useful summary of the issues relating to biosimilar insulins and what it means for prescribers.
- The Advent of Biosimilars for the Treatment of Diabetes: Current Status and Future Directions - This is another good review of the key issues relevant for biosimilar insulins.