Biosimilars

 
 

A biosimilar medicine is a biological medicine manufactured to be similar to an existing licensed ‘reference’ biological medicine. A biosimilar has no meaningful differences from the original biological medicine (originator) in terms of quality, safety or efficacy. Due to the complex manufacturing process, as these medicines are made from living organisms using biotechnology techniques, biosimilars are not classed as ‘generic’ medicines, because they are not absolutely identical to the original biologic medicine.

NIHR (National Institute for Health Research) has developed an informative animation to explain what a biosimilar is and why they are now being introduced.


Why you could be asked to switch to a biosimilar medicine 

Biosimilar medicines represent very good value for the NHS since they are often much less costly than the originator medicine. Therefore the NHS is asking clinical teams, in discussion with individual patients, to ensure they are using the best value biological medicines – whether that is the originator biological medicine or a new biosimilar medicine – so that the money saved can be reinvested in new medicines and treatments for patients.

Royal College of Nursing (RCN) and NHS England (NHSE) briefing on best value biological medicines for specialist nurses

Biosimilar medicines and switching programmes in RA. 

Adalimumab Patient Working Group - August 2018
NRAS is working with NHSE as a member of their main National Biosimilar Programme Board to ensure that the needs of patients with RA are represented at national level in regard to switching programmes.

NRAS is also a key member of the NHSE Adalimumab Patient Working Group advising NHS England on patient issues around switching to Adalimumab (Humira) biosimilars which will be coming to the UK market at the end of the year when Adalimumab comes off patent. This will introduce another 4 biosimilar therapies to those which already exist for other originator biologic therapies:  Etanercept (Enbrel) – Benepali, Rituximab (Mabthera) – Rituxan and Infliximab (Remicade) – Inflectra and Remsima.
We and patient organisations representing people with other auto-immune conditions such as Crohns and Colitis, Psoriatic Arthritis and Axial Spondyloarthritis have collaborated with NHSE to develop a ‘Frequently Asked Questions’ document about the introduction of the new biosimilars for Adalimumab and a template letter which hospitals can use to inform patients about switching from Adalimumab. Both of these documents are now available on the Specialist Pharmacy Service website.
View patient letter.

Biosimilar medicines Workshops Report – March 2016 
The above report, following two workshops held by NHS England back in March in London and Leeds has now been released and I attach a pdf copy here which you may wish to read. It reflects the views of many different stakeholders who were involved in attending either of the above workshopsand describes further work which will be done at a national level to ensure that the introduction of biosimilar drugs to the UK market is managed in the best way going forward for patients, clinicians, commissioners, industry and others involved.

Ailsa

Both Clare Jacklin, NRAS Director of External Affairs, and I were involved in delivering ‘patient experience’ sessions in partnership with two leading rheumatologists at both workshops and I have subsequently been invited onto the NHSE National Biosimilar Medicines Programme Board and will be working closely with this group to ensure that the patient voice is represented at a national level.

If you have any general questions about biosimilars, do contact our Helpline who are available between 09.30-16.30 Mon-Fri. If you have experience of being switched onto a biosimilar which you would like to share with us, good or bad, please email me: ailsa@nras.org.uk 

Ailsa Bosworth MBE
Chief Executive, NRAS

Other downloads

Biosimilars Position paper
revised 2019

BSR Biosimilars Position Statement (Oct 2018)

Biosimilars Stakeholder Event 2014 
includes report 

NRAS Spring 2015 Article

NRAS Spring 2016 Article

What is a Biosimilar Medicine? - Biosimilars Guide