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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 rituximab and the TNF-alpha inhibitors (e.g. adalimumab, etanercept, and infliximab) have revolutionized rheumatoid arthritis (RA) care, significantly brightening the outlook for the global population affected by this potentially crippling condition. The high cost of biologics currently puts them beyond the reach of many eligible patients – but, as some frontline 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.

Rheumatoid arthritis – a significant global health issue   +

Rheumatoid arthritis affects up to 1% of the global population and often strikes during the most productive years of adulthood.1,2 Up to 40% of patients leave work completely within 5 years of an RA diagnosis because of increasing disability.3 In addition to constant pain, fatigue and deformity, people with RA are at greater risk of developing other conditions including cardiovascular disease, infections, and mental health disorders.1 The mortality risk is double that for people of the same age without the condition.1
The advent of biologics has revolutionized RA care...   +

Biologics such as rituximab and the TNF-alpha inhibitors (e.g. adalimumab, etanercept and infliximab) have revolutionized RA care.4 Fifteen years ago, patients for whom conventional disease-modifying anti-rheumatic drug (DMARD) therapy was inadequate could face a bleak future.5 For many, management was a balancing act between the consequences of poorly controlled disease and the negative effects of long-term corticosteroid use.5 The development of effective and well-tolerated biologic DMARDs has dramatically improved the overall prognostic picture in RA and made remission a realistic goal.5 In addition, mounting clinical evidence shows that combination treatment with methotrexate (MTX) and a biologic DMARD is superior to MTX alone, not only in MTX-treated patients but also in treatment-naïve patients.5 And highly anticipated studies are underway to confirm the exciting finding that patients with RA who have achieved remission after early biologic treatment are able to sustain this after dose reduction and even complete cessation of the biologic prescribed.6,7

"Rheumatologists can radically alter the trajectory of rheumatoid arthritis with appropriate use of biologics, which can prevent joint destruction and disability, avert expensive joint replacement surgery, and provide our patients the opportunity to maintain daily functions."
Tim Laing, MD, Government Affairs Committee Chair,
American College of Rheumatology18

...but many patients can't benefit because of the cost   +

However, the reality is that many patients with RA 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 DMARDs may be out of reach for virtually the entire population.8 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 DMARDs is often unsustainable, with many patients denied them. For example, in more than 50% of European countries, the annual cost of a biologic DMARD can exceed the per capita gross domestic product (GDP) by as much as 11 times, meaning that almost 40% of the total European population has severely restricted access to biologic DMARDs.9 In the USA, a 2014 survey of more than 100 US rheumatologists found that over 80 percent encounter moderate-to-strong control by payers when prescribing biologics for RA.10 Improving patient access to these innovative therapies is clearly an urgent priority.

UK: "Thousands of NHS patients with previously untreatable rheumatoid arthritis could be denied a new 'smart' drug [tocilizumab] to ease their agony because it is too expensive."11

USA: "I was surprised to see almost half of RA patients are spending $5,000 a year out of pocket... it's unsettling because we have these drugs, which are terrific, and some patients will not have access to them."12

Latin America: "Despite the impairment caused by their disease, only 13 percent of rheumatoid arthritis patients in Brazil who are eligible for biologic therapy according to clinical guidelines are actually using a biologic."13

Patent expiry permits introduction of biosimilars   +

The costs of modern RA biologics reflect the scientific innovation and the investment required to support biotechnological research and development. But it puts the 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.

"In the treatment of patients with rheumatoid arthritis, EULAR recommends the initiation of biological DMARDs when synthetic DMARDs fail. However, biologicals are costly and this can influence whether patients gain access to these life-changing drugs or not."1

"If the patients who need these medications cannot access them due to excessive cost-sharing requirements, we are costing our economy millions of dollars each year in additional healthcare costs and lost wages."
Tim Laing, MD, Government Affairs Committee Chair,
American College of Rheumatology13

There’s no quick-fix solution – but, as some frontline RA biologics start to approach patent expiry, the opportunity arises for new manufacturers to develop more affordable biosimilars. Biosimilar versions of infliximab 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, and a rituximab biosimilar has been approved in the EU and South Korea. The first adalimumab biosimilar has now been approved in both the US and the EU. Both the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) have highlighted the importance of access to biosimilars in rheumatoid arthritis. In addition, EULAR has officially recommended that biosimilars should be used in preference to more costly originator biologics whenever possible.

Become a clinical investigator for biosimilars used in RA   +

QuintilesIMS is actively supporting the development of biosimilars for RA 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 RA 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 RA treatment to a far wider population. 

Learn more about working with QuintilesIMS 

References   +

1. Centers for Disease Control and Prevention. Rheumatoid arthritis. http://www.cdc.gov/arthritis/basics/rheumatoid.htm. Accessed 30 January 2015.
2. Centers for Disease Control and Prevention. Arthritis-related statistics. http://www.cdc.gov/arthritis/data_statistics/arthritis_related_stats.htm. Accessed 30 January 2015.
3. National Rheumatoid Arthritis Society. European Fit for Work report. http://www.nras.org.uk/european-fit-for-work-report. Accessed 30 January 2015.
4. Scheinberg MA & Kay J. The advent of biosimilar therapies in rheumatology—“O Brave New World”. Nat Rev Rheumatol (2012) 8:430–436.
5. Horton SC & Emery P. Biological therapy for rheumatoid arthritis: where are we now? Br J Hosp Med (Lond) (2012) 73:12–18.
6. Emery P, Hammoudeh M, FitzGerald O et al. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med (2014) 371:1781–1792.
7. Emery P, Burmester GR, Bykerk VP et al. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis (2015) 74:19–26.
8. 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.
9. 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.
10. Decision Resources, 20 August 2014. Payers exert cost controls on high-cost biologics to treat autoimmune conditions. http://www.decisionresources.com/News-and-Events/Press-Releases/Payers-Exert-Cost-Controls-8-20-14. Accessed 31 January 2015.
11. Daily Mail Online, 8 October 2009. Rheumatoid arthritis drug which eases pain 'is too expensive for the NHS.' http://www.dailymail.co.uk/health/article-1218887/Rheumatoid-arthritis-drug-eases-pain-expensive-NHS.html. Accessed 30 January 2015.
12. Rheumatoidarthritis.net, 12 December 2013. RA costs more than you may think – patient out of pocket expenses. http://rheumatoidarthritis.net/living/ra-costs-more-than-you-may-think-patient-out-of-pocket-expenses/. Accessed 30 January 2015.
13. RedOrbit, 14 September 2013. Biologic treatment of rheumatoid arthritis is low in Brazil, according to Kantar Health Research. http://www.redorbit.com/news/health/1112947999/biologic-treatment-of-rheumatoid-arthritis-is-low-in-brazil-according/. Accessed 30 January 2015.
14. Gabi Online, 15 February 2013. Inequality in Europe over access to biologicals for arthritis. http://gabionline.net/Reports/Inequality-in-Europe-over-access-to-biologicals-for-arthritis. Accessed 30 January 2015.
Video Spotlights
Investigator perspective: Rheumatoid Arthritis: Improving access to biologics
Investigator perspective: Rheumatoid Arthritis: Improving access to biologics
Investigator perspective: Extrapolation: Gaining approval for additional indications
Investigator perspective: Extrapolation: Gaining approval for additional indications
Considering a biosimilars trial?
Considering a biosimilars trial?
Investigator perspective: Engaging patients in biosimilars trials
Investigator perspective: Engaging patients in biosimilars trials