Biologics have revolutionised treatment across therapeutic areas:1
Immune-Mediated Inflammatory Disorders (IMID) are progressive diseases, requiring timely and continuous treatment. Current guidelines often reserve these treatments for patients with more severe disease and/or patients who have failed to respond to multiple other treatments.1 In some countries, access to biologics may then be further limited by the implementation of national eligibility and reimbursement criteria,1 creating an unmet need in many countries worldwide.
Adapted from Baumgart DC, Misery L, et al. Front Pharmacol 2019;10:279
Associations between affordability and the uptake of biosimilars in Crohn’s disease
Cz=Czech Republic; D=Germany; Es=Spain; Fr=France; Hu=Hungary; Lv=Latvia; Pl=Poland; Ro=Romania; Se=Sweden; Sk=Slovakia
Adapted from Pentek M, Lakatos PL, et al, World J Gastroenterol 2017;23:6294–6305
Biosimilars are mainly approved in 3 key fields:1
..though the potential use of biosimilars in other emerging treatment areas is growing – e.g. ophthalmology,2 diabetes,3 controlled ovarian stimulation for IVF,4 and hematopoietic cell transplantation.5
Biologics account for a considerable portion of global medicine spending
Global spending US$, MAT Q2 2018
Potential benefits of biosimilars: driving down price
Change in price per treatment day since introduction of biosimilar
Adapted from Ebbers H and Schellekens H. Drug Discov Today 2019;10:1963–1967
Biosimilarity is demonstrated through extensive structural and functional comparability studies and a tailored clinical program
Figure adapted from Araújo FC, et al. Pharmacol Res 2019;149:104467.
PD, pharmacodynamics; PK, pharmacokinetic
Adapted from Araújo FC, et al. Pharmacol Res 2019; 149:104467.
Clinical trials are tailored to confirm biosimilarity and to address any questions that may remain from previous analytical or functional studies
Comparative pharmacokinetic/pharmacodynamic studies
Comparative clinical efficacy and safety trial studies
Biosimilars in the EU: Information guide for healthcare professionals. Available from: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf Accessed July 2021
“The study population should generally be representative of approved therapeutic indication(s) of the reference product and be sensitive for detecting potential differences between the biosimilar and the reference”
Adapted from EMA. Guideline on similar biological medicinal products. 18 December 2014. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf. Accessed July 2021