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Evaluation of Tumour Necrosis Factor Inhibitor Biosimilar Use in the UK for psoriasis: a study from the British Association of Dermatologists Biologics and Immunomodulator Register


   Faculty of Biology, Medicine and Health

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  Dr Zenas Yiu, Dr Richard Warren, Dr Mark Lunt  No more applications being accepted  Funded PhD Project (Students Worldwide)

Manchester United Kingdom Data Analysis Epidemiology Nursing & Health Pharmacy Statistics

About the Project

Biosimilars are biologic products that are highly similar to reference licensed originator compounds. As biosimilars are priced competitively, their introduction for the treatment of psoriasis promises to reduce healthcare costs. However, as biologic products are manufactured from living cell lines, there are structural differences between the biosimilar and originator product. However, regulators do not require studies of clinical efficacy, or long-term safety for biosimilars across disease states prior to licensing. There is little robust evidence for the effectiveness and safety of biosimilars for the treatment of psoriasis in the real-world setting currently.

The aim of this pharmacoepidemiological study is to evaluate the use of tumour necrosis factor inhibitor (TNFi) [adalimumab, etanercept, and infliximab] biosimilars in the UK for the treatment of psoriasis. The study has two objectives: the first is to identify the distribution and uptake of TNFi biosimilars, inclusive of both starters and switchers, in the UK over time. The second objective is to compare the effectiveness and safety of TNFi biosimilars to their originator product using target trial emulation and prevalent new user study approaches. The proposed project will utilise data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). The BADBIR is a world-leading longitudinal, observational, web-based study of patients with moderate-to-severe psoriasis who are receiving either conventional systemic or biologic therapies for psoriasis.

Entry Requirements

Applicants are expected to hold (or about to obtain) a minimum upper second class undergraduate honours degree (or equivalent) in Statistics, Biomedical Sciences, Medicine, Pharmacy. A Masters degree in a relevant subject and/or experience in Epidemiology / Biostatistics / Pharmacoepidemiology / Public Health is desirable.

For information on how to apply for this project, please visit the Faculty of Biology, Medicine and Health Doctoral Academy website (https://www.bmh.manchester.ac.uk/study/research/apply/). Informal enquiries may be made directly to the primary supervisor. You MUST also submit an online application form - choose PhD Dermatological Sciences.

Equality, Diversity & Inclusion

Equality, diversity and inclusion is fundamental to the success of The University of Manchester, and is at the heart of all of our activities. The full Equality, diversity and inclusion statement can be found on the website https://www.bmh.manchester.ac.uk/study/research/apply/equality-diversity-inclusion/


Funding Notes

This project is funded by the Psoriasis Association. Studentship funding is for a duration of three years to commence in September 2021 and covers UK tuition fees and a UKRI stipend (£15,609 per annum 21/22). The University of Manchester aims to support the most outstanding applicants from outside the UK. We are able to offer a scholarship that will enable full studentship to be awarded to international applicants. This full studentship will only be awarded to exceptional quality candidates, due to the competitive nature of this funding.

References

1. British Association of Dermatologists' Position Statement on Biosimilars. British Association of Dermatologists. https://www.bad.org.uk/shared/get-file.ashx?id=3615&itemtype=document. Accessed 01/11/2020.
2. Desai RJ, Kim SC, Curtis JR, et al. Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars. Pharmacoepidemiol Drug Saf. 2020;29(7):757-769.
3. Cohen AD, Wu JJ, Puig L, et al. Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice. Br J Dermatol. 2017;177(6):1495-1502.
4. Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016;183(8):758-76
5. Suissa S, Moodie EE, Dell'Aniello S. Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores. Pharmacoepidemiol Drug Saf. 2017;26(4):459-468