Adalimumab biosimilar switch study (ABSS)
Research type
Research Study
Full title
A questionnaire-based study: understanding the impact on patients switching from the adalimumab originator, Humira to the adalimumab biosimilar, Idacio.
IRAS ID
329162
Contact name
Mark Samaan
Contact email
Sponsor organisation
GSTT Foundation Trust, Gastroenterology department
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
Biologic medicines have revolutionised the treatment of Inflammatory Bowel Disease (IBD) that previously had limited treatment options . Despite the overwhelming beneficial patient and disease related outcomes, the cost of these medicines remains a challenge and in some circumstances, can result in access limitations.
In 2018, adalimumab was the largest single drug spend for the NHS, therefore, when biosimilar versions became available due to the originator product’s patent expiry, their adoption into standard practice was heavily encouraged.
Changing therapy to a biosimilar product can be defined as “non-medical switching”, whereby swapping to an equivalent product is not related to improving efficacy, safety or convenience but is driven by attempting to reduce the cost of the medication or service provided.
Guy’s & St Thomas’ has a total IBD cohort of approximately 6000 patients, of whom, nearly 400 are treated with adalimumab.
The vast majority of these underwent a non-medical adalimumab switch between 2020-2021.
We propose to collect a questionnaire from thIS patient population, to try to understand their experience of this non-medical switching process.
REC name
London - Central Research Ethics Committee
REC reference
24/LO/0280
Date of REC Opinion
29 Apr 2024
REC opinion
Further Information Favourable Opinion