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

Biosimilars Knowledge Connect

Patent expiry permits introduction of less costly biologics known as 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.

Psoriasis quote

Access quotes

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 less costly versions, which are most commonly known as biosimilars.* Infliximab biosimilars have already been approved in several regions including the EU, US, Australia, Canada, and Japan. Two etanercept biosimilars have been approved in South Korea, and one of these was approved in the EU in January 2016. Evaluation of biosimilar candidates for adalimumab is also in progress.

*also known as follow-on biologics, subsequent-entry biologics and biocomparables, among others.

What are biosimilars?   +

Unlike the generics of the chemical drug world, biosimilars are not exact copies of originator biologics, as it is not possible for a new manufacturer to precisely replicate the highly complex and sophisticated production processes. However, extensive regulatory requirements are designed to ensure that candidate biosimilars must be rigorously compared with their originators both analytically and clinically, to establish that quality, efficacy, and safety are all a very close match. By January 2016, 22 biosimilars in a range of therapy areas have been launched in Europe with no adverse clinical consequences compared with their originators19, 20 – and have resulted in significant cost savings.21

The extent of the testing required means that biosimilars can’t be as heavily discounted as chemical generics. The average savings are projected to be 20–30%,22 but they could well be higher. For a biologic that typically costs USD $10,000 to $30,00023 per patient per year, these savings are highly worthwhile, especially as some patients with psoriasis may require lifelong treatment.24,25 In addition, the introduction of competition may prompt the manufacturers of originator biologics to reduce their prices and to consider investing in innovative new products as they seek new competitive advantages. 

Learn more about BiosimilarsRegulatory Requirements, and Biosimilars by Region.

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 Quintiles.

Why partner with Quintiles?   +

  • We’ve worked with tens of thousands of clinical research sites worldwide since 1982
  • We helped to develop or commercialize all of the top 50 best-selling biotechnology products or compounds of 2013
  • We’ve supported the development of biosimilars for more than 10 different originator biologics including monoclonal antibodies
  • We established Biosimilars Knowledge Connect in 2012 to educate and engage investigators in biosimilar research
References   +

1. World Health Organization, 5 April 2013. Psoriasis. Report by the Secretariat. Accessed 30 January 2015.
2. Celgene, 15 September 2014. 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. Accessed 30 January 2015.
5. Radtke MA & Augustin M. Biosimilars in psoriasis: What can we expect? 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. 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. 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). Accessed 30 January 2015.
17. BioSpectrum, 12 August 2013. Biocon's novel anti-psoriasis biotech drug Itolizumab released in India. psoriasis-biotech-drug-itolizumab-released-india/page/2. Accessed 30 January 2015.
18. PRMA Insights: Pricing and reimbursement success in psoriasis. Accessed 30 January 2015.
19. Ebbers HC, Crow SA, Vulto AG & Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol (2012) 30:1186–1190.
20. McCamish MC. & Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther (2012) 91:405–417.
21. Rovira J, Espín J, García L & Olry de Labry A, 2011. The impact of biosimilars’ entry in the EU market. Andalusian School of Public Health.
22., 30 September 2014. New report details players and pipelines in the biosimilar space. Accessed 30 January 2015.
23. WebMD. Is your psoriasis treatment on target for you? Accessed 31 January 2015.
24. Papp KA. The long-term efficacy and safety of new biological therapies for psoriasis. Arch Dermatol Res (2006) 298(1):7–15.
25. National Psoriasis Foundation. Frequently asked questions. Accessed 31 January 2015.
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Investigator perspective: Extrapolation: Gaining approval for additional indications
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Investigator perspective: Rheumatoid Arthritis: Improving access to biologics
Considering a biosimilars trial?
Considering a biosimilars trial?