They have revolutionised patient treatment by offering new and effective medicines for acute and chronic conditions including a wide range of inflammatory and autoimmune diseases and cancer.

A biosimilar medicine is a biological medicine that is developed to be highly similar and clinically equivalent to an existing biological medicine.   A biosimilar medicine is not the same as a generic medicine, which would have an identical molecular structure to its reference medicine. 

When the patent expires for an individual originator medicine, biosimilar medicines can be introduced.  This results in increased competition in the biological medicines market, which presents an opportunity to realise value for the NHS and potentially support increased access to treatments for patients. 

A number of biosimilar medicines are already in use but there is also a crowded pipeline, so the market is expected to become increasingly complex in the months and years to come. 

Ensuring that key stakeholders have a good understanding of biological medicines, including biosimilar medicines, will be crucial to ensure appropriate use and that the NHS makes the most of the opportunity presented by increased competition.

ABPI position papers on biological medicines, including biosimilar medicines

Representing both originator biological medicine manufacturers and biosimilar medicine manufacturers, the ABPI works to raise awareness and understanding of key considerations related to biological medicines, including biosimilar medicines. 

Drawing on the insights of originator and biosimilar manufacturers, the ABPI has a unique perspective on the opportunities and challenges presented by the increasingly complex biological medicines market.  The ABPI has prepared a number of position papers on topics related to biological medicines, including biosimilar medicines.  More detail on these are included below:

Statement on NHS England Commissioning Framework for Biological Medicines

In September 2017, the ABPI responded to a new NHS commissioning framework for biological medicines (including biosimilars) that "aims to support commissioners to act promptly to make the most of the opportunity presented by increased competition amongst biological medicines, including biosimilar medicines". 

This statement can be found here.

Overarching position paper

In 2013, the ABPI prepared its original position on biological medicines.  The position includes recommendations on areas requiring action by regulators, health technology assessment agencies, NHS commissioners and healthcare professionals who prescribe and dispense biological medicines. 

The ABPI's position on biological medicines, including biosimilars can be found here.

National collaboration on biological medicines, including biosimilar medicines

The ABPI has supported a collaborative approach to policy development for biological medicines, including biosimilars, which has been unique in Europe and has encouraged clear and consistent national communications.

The ABPI works in partnership with NHS England, Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), National Rheumatoid Arthritis Association, NHS Clinical Commissioners, the Royal Pharmaceutical Society (RPS), the BioIndustry Association and the British Biosimilars Association to improve awareness and understanding of biological medicines, including biosimilar medicines.

The partner organisations all sit on the National Biosimilar Medicines Programme Board, which is chaired by Keith Ridge, Chief Pharmaceutical Officer, NHS England.  This regular forum for all biosimilars stakeholders has provided the foundations for a coordinated and consistent approach to policy development in England.

A number of resources have been developed through the course of this collaboration.

What is a biosimilar medicine? September 2015
This document provides key information about biological medicines, including biosimilar medicines, in a question and answer format. It is intended to support the safe, effective and consistent use of biological medicines across the NHS.

NHS England Biosimilar Workshop Report July 2016
This document summarises the discussions of two workshops on biosimilar medicines, hosted by NHS England in March 2016. Participants at the workshops included local stakeholders with decision-making responsibility for commisioning, prescribing, dispensing and monitoring biological medicines, as well as patient representatives. Discussions focused on how to ensure an appropriate and patient-centred approach to the use of biosimilar medicines in order to benefit from the opportunity presented by increased competition between different biological medicines, including biosimilar medicines.

Biological medicines: what you need to know about manufacturing? July 2016
All biological medicines are complex and sensitive to their manufacturing process in ways that chemically synthesized, small molecule medicines are not. This paper helps to clarify the often confused terminology of batch-to-batch variation, manufacturing change and biosimilarity.

Contact ABPI regarding biological medicines, including biosimilar medicines

If you would like to contact the ABPI about biological medicines, including biosimilars, please email Dr Sheuli Porkess, Interim Executive Director - Research, Medical and Innovation and Dr Paul Catchpole, Director - Value & Access.