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Biosimilar clinical trials provide participants with immediate access to active biologic therapy at no cost and ultimately contribute to more affordable treatment worldwide

Biologics such as the TNF-alpha inhibitors (which include adalimumab, etanercept, and infliximab) have revolutionized psoriasis care, significantly brightening the outlook for the global population affected by this disfiguring and potentially debilitating disease. The high cost of biologics currently puts them beyond the reach of many eligible patients – but, as some modern biologics start to approach patent expiry, new manufacturers are able to begin developing less costly versions known as biosimilars. For regulatory approval, biosimilars need to demonstrate comparable safety and efficacy to the originator biologic in a head-to-head clinical trial.

Psoriasis – a major global health issue   +

Psoriasis affects as many as 2% of the world’s population1 and has recently been acknowledged by the World Health Organization (WHO) as a serious condition in need of improved care.2 People with psoriasis can experience persistent discomfort, as well as feelings of shame and isolation, and are at greater risk of developing co-morbidities including diabetes, cardiovascular and rheumatologic diseases.1 Psoriatic arthritis, which is frequently debilitating, is thought to affect up to 42% of patients with psoriasis.3 Psoriasis has a huge economic impact: in the USA alone, approximately 56 million hours of work are lost and roughly USD $3 billion is spent on treatment each year.4 Discrimination against psoriasis sufferers for their skin lesions is common and can further limit employability, especially in developing nations where the condition is often mistaken for lesions from human immunodeficiency virus (HIV), leprosy, or bad hygiene.4
The advent of biologics has revolutionized psoriasis care...   +

Biologics such as the TNF-alpha inhibitors (which include adalimumab, etanercept, and infliximab) have revolutionized psoriasis care.5 Fifteen years ago physicians had few options to treat severe or intractable cases,6 but biologics have dramatically improved prognosis and provide valuable alternatives for patients with treatment-resistant disease.5,7 Psoriasis biologics can visibly reduce lesions and may also reduce the occurrence of co-morbidities.6,8 In addition, there is mounting clinical evidence of a therapeutic synergy between biologics and more conventional psoriasis treatments, sometimes without an increase in adverse events.6 Many national guidelines recommend biologics for the treatment of psoriasis and research into psoriasis continues to accelerate, rapidly expanding the therapeutic options available.9,10,11
...but many patients can't benefit because of the cost   +

Unfortunately many patients with psoriasis are not able to reap the benefits of biologics. The reason, of course, is cost. In some developing nations, where healthcare focuses on fatal diseases, biologic TNF-alpha inhibitors for conditions like psoriasis may be out of reach for virtually the entire population.12 Even in developed nations large discrepancies in patient access to biologics exist. In some countries, funding is generally made available but in others the cost of biologic TNF-alpha inhibitors is often unsustainable, with many patients denied them.13,14 For example, in more than 50% of European countries, the annual cost of a TNF-alpha inhibitor can exceed the per capita gross domestic product (GDP) by as much as 11 times, meaning that access is severely restricted in almost 40% of the total European population.13 In the USA, lack of reimbursement by insurers is one of the main reasons why patients with psoriasis discontinue biologic treatment even when it has been of significant help to them.15

USA: "Dave, age 70, has to choose between treating his psoriasis and saving for retirement because the copayments on his biologic drug cost several hundred dollars per month."14

Philippines: "It may be the most exciting form of therapy in developed countries, but unfortunately, these drugs are unreachable to most of our patients here in the Philippines."16

India: "Currently, due to high prices most of the patients discontinue treatment of biological drugs mid-course."17

Patent expiry permits introduction of biosimilars   +

The costs of modern psoriasis biologics reflect the scientific innovation and the investment required to support biotechnological research and development. But it puts these treatments beyond the reach of many people. Pursuit of innovative new drugs is clearly of great importance, but so is broadening patient access to the treatments we have now.

"New medications that significantly reduce psoriasis and other inflammatory diseases are often not available, are very expensive, and not covered by all health care plans."
International Federation of Psoriasis Association4

"Psoriasis is perceived by payors to have only cosmetic implications. As a consequence, it is given low priority in treatment funding agendas, making the pricing and reimbursement negotiations of innovative but expensive treatments a challenge. The reality for patients, however, is that psoriasis is a chronic and debilitating inflammatory condition that has a heavy impact on health-related quality of life."18

There’s no quick-fix solution – but, as some modern biologics used for psoriasis start to approach patent expiry, the opportunity arises for new manufacturers to develop more affordable biosimilars. Infliximab biosimilars have already been approved in several regions including the EU, US, Australia, Canada, and Japan. Etanercept biosimilars have been approved in the EU, US, and South Korea. Importantly, an innovative "triple switch" 52-week study in patients with psoriasis (n=531) reported that three successive switches between branded etanercept (Enbrel®) and a biosimilar version, showed no clinically meaningful differences between the two treatments.19 The first adalimumab biosimilar has now been approved in both the US and the EU.

Become a clinical investigator for biosimilars used in psoriasis   +

Quintiles is actively supporting the development of biosimilars for psoriasis and we invite you to join us as a clinical investigator. The patients you enroll in these studies will all receive active therapy, either with a branded biologic or a biosimilar candidate at no cost to them or to their insurers. Even if you perceive that patient access to biologics for psoriasis is not a critical issue in your own country, getting involved in biosimilar clinical trials will give you the opportunity to help maintain the high standards required for biosimilar studies, gain experience in an area of research projected to expand significantly, and be part of a global mission to bring the benefits of modern psoriasis treatment to a far wider population.

Learn more about working with QuintilesIMS 

References   +

1. World Health Organization, 5 April 2013. Psoriasis. Report by the Secretariat. http://apps.who.int/gb/ebwha/pdf_files/EB133/B133_5-en.pdf. Accessed 30 January 2015.
2. Celgene, 15 September 2014. Global burden of psoriasis recognized by WHO. https://www.celgene.com/global-burden-of-psoriasis-recognized-by-who/. Accessed 30 January 2015.
3. Gladman DD, Antoni C, Mease P et al. Psoriatic arthritis: Epidemiology, clinical features, course, and outcome. Ann Rheum Dis (2005) 64(Suppl 2):ii14–ii17.
4. International Federation of Psoriasis Associations (IFPA). Psoriasis is a serious disease deserving global attention. http://www.ifpa-pso.org/getfile.ashx?cid=279366&cc=3&refid=18. Accessed 30 January 2015.
5. Radtke MA & Augustin M. Biosimilars in psoriasis: What can we expect? http://onlinelibrary.wiley.com/doi/10.1111/ddg.12294/pdf. J Dtsch Dermatol Ges (2014) 12:4, Article first published online: 2 Apr.
6. Mandell BF & Sobell JM. The role of TNF inhibitors in psoriatic disease. Semin Cutan Med Surg (2014) 33(4 Suppl):S64–S68.
7. Burfield L & Burden AD. Psoriasis. J R Coll Physicians Edinb (2013) 43(4):334–338.
8. Prussick R & Prussick L. Biologic therapies for psoriasis in 2013: Do we use them enough? Pract Dermatol (2013) Feb:32–34. http://practicaldermatology.com/pdfs/PD0213_CF_Prussick.TP.pdf. Accessed 30 January 2015.
9. Sobell JM & Leonardi CL. Therapeutic development in psoriasis. Semin Cutan Med Surg (2014) 33(4 Suppl):S69–S72.
10. Smith CH, Anstey AV, Barker JNWN et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009. Br J Dermatol (2009) 161:987–1019. 
11. Menter A, Gottlieb A, Feldman SR et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol (2008) 58(5):826–850.
12. Osiri M & Maetzel A. The economic burden of rheumatoid arthritis: Asia/Thailand perspective. In: Handbook of Disease Burdens and Quality of Life Measures (2010) 1733–1750. 
13. Putrik P, Ramiro S, Kvien TK et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis (2014) 73:198–206. 
14. National Psoriasis Foundation. Access to fair and affordable treatments a struggle. http://www.psoriasis.org/access-care/access-to-fair-and-affordable-treatments-a-struggle. Accessed 30 January 2015.
15. Armstrong AW, Robertson AD, Wu J et al. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States. Findings from the National Psoriasis Foundation Surveys, 2003–2011. JAMA Dermatol (2013) 149(10):1180–1185.
16. International Psoriasis Council. IPC Psoriasis Review (2010) 6(1). http://www.psoriasiscouncil.org/docs/ipcpsoriasisreview_may2010.pdf?LanguageID=EN-US. Accessed 30 January 2015.
17. BioSpectrum, 12 August 2013. Biocon's novel anti-psoriasis biotech drug Itolizumab released in India. http://www.biospectrumasia.com/biospectrum/news/193291/biocons-novel-anti psoriasis-biotech-drug-itolizumab-released-india/page/2. Accessed 30 January 2015.
18. PRMA Insights: Pricing and reimbursement success in psoriasis. http://www.prmaconsulting.com/psoriasis/psoriasis-insights-brochure.pdf. Accessed 30 January 2015.
19. Novartis, 18 November 2016. Innovative study with three treatment switches confirms Sandoz biosimilar etanercept has equivalent efficacy to originator. https://www.novartis.com/news/media-releases/innovative-study-three-treatment-switches-confirms-sandoz-biosimilar-etanercept. Accessed 27 March 2017.

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