Healthcare systems
Biosimilar use in progressive disease
In the past two decades, the treatment of debilitating, progressive diseases including immune-mediated inflammatory diseases (IMIDs) has been transformed by the introduction of biological therapies.1
Reference:
- Edwards CJ, Hercogová J, et al. Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases. Expert Opinion on Biological Therapy 2019; 19(10):1001-1014
Potential benefits of biosimilars
Reference:
Adapted from IQVIA. Advancing biosimilar sustainability in Europe. Available at: http://www.boussiasconferences.gr/files/_boussias_conferences_content/presentations/ biosimilars_conference/2018/tomasz_kluszczynski_biosimilars_18.pdf. July 2021
Unmet need and limited access
Current guidelines often reserve these drugs 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.
Reference:
- Edwards CJ, Hercogová J, et al. Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases. Expert Opinion on Biological Therapy 2019; 19(10):1001-1014
Access to biologics is linked to affordabilitiy
Associations between affordability and the uptake of biosimilars in Crohn’s disease
Cz=Czech Republic; De=Germany; Es=Spain; Fr=France; Hu=Hungary; Lv=Latvia; Pl=Poland; Ro=Romania; Se=Sweden; Sk=Slovakia
*Prevalence is the number of people with the confirmed diagnosis of Crohn's disease in the year 2017.
Reference:
Adapted from Pentek M, Lakatos L, et al, Access to biologicals in Crohn's disease in ten European countries. World J Gastroenterol 2017. 23(34):6294-6305
For more information on improving access to biosimilars, please click on the following video where Peter Taylor, Professor of Musculoskeletal Sciences discusses ‘Optimizing patient management in RA - Can we live up to patient expectations?’, at the satellite symposium at EULAR congress 2019
Can we live up to patient expectations?
19/11/2021 | 52:37
Biosimilars drive down price
Potential benefits of biosimilars: driving down price
Change in price per treatment day since introduction of biosimilar
Reference:
Adapted from Quintiles IMS. The impact of biosimilar competition in Europe. September 2018. Available at: https://ec.europa.eu/docsroom/documents/31642/attachments/1/translations/en/renditions/pdf. Accessed July 2021
Increased use of biologics
Biosimilar approvals have accelerated in recent years:1
Reference:
Ebbers, Schellekens H, et al, Are we ready to close the discussion on the interchangeability of biosimilars? Drug Discov Today. 2019. 24(10):1963-1967
Estimated past and anticipated patent expirations of selected major biologics (antibodies)
EU provides 10 years of exclusivity (8 years data exclusivity and 2 years market exclusivity + 1 year possible extension), US BPCI Act provides 12 years exclusivity (years data exclusivity and 8 years market exclusivity). The intellectual property for biologicals can involve multiple patents and patent timelines for each individual product and therefore it is difficult to give an exact date for patent expiry for biologicals. It should therefore be noted that the dates given are only estimates. Where patent expiry dates cannot be found, expiry dates given are based on 10 years exclusivity (EU) and 12 years exclusivity (US).
*Except for France, Italy, Spain and the UK
** In the UK. Other EU markets follow on 28 August 2015; patent protecting the cells that make certain levels of erythropoietin last until 26 May 2015.
***Although the composition of matter patent covering Humira expired in December 2016, AbbVie has stated that non-composition of matter patents covering Humira expire no earlier than 2022.:
Reference:
Available from: http://gabi-journal.net/patent-expiry-dates-for-biologicals-2018-update.html. Accessed 18th February 2020
Estimated past and anticipated patent expirations of major biologics (non-antibodies)
EU provides 10 years of exclusivity (8 years data exclusivity and 2 years market exclusivity + 1-year possible extension), US BPCI Act provides 12 years exclusivity (4 years data exclusivity and 8 years markets exclusivity). The intellectual property for biologicals can involve multiple patents and patent timelines for each individual product and therefore it is difficult to give an exact date for patent expiry for biologicals. It should therefore be noted that the dates given are only estimates. Where patent expiry dates cannot be found, expiry dates given are based on 10 years exclusivity (EU) and 12 years exclusivity (US).
*Includes 6-month pediatric extension
Reference:
Available from: GaBI. Patent expiry dates for biologicals: 2018 update. February 2019. Available from: http://gabi-journal.net/patent-expiry-dates-for-biologicals-2018-update.html. Accessed July 2021