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Rheumatoid Arthritis

As a biosimilar investigator, you can offer your patients 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

Tim Laing

...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.

Biosimilars Rheumatoid Arthritis

Patent expiry permits introduction of less costly biologics known as 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.

Biosimilars Rheumatoid Arthritis


Tim Laing

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 less costly versions, which are most commonly known as biosimilars.* Biosimilar versions of infliximab 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 and rituximab 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 had been launched in Europe with no adverse clinical consequences compared with their originators15,16 – and have resulted in significant cost savings.17

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%,18 but they could well be higher. For a biologic DMARD, which typically costs USD $10,000 to $30,000 per patient per year,19,20 these savings are highly worthwhile, especially as some patients may require treatment for more than a decade.21 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 RA   +

Quintiles 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 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. 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.
15. Ebbers HC, Crow SA, Vulto AG & Schellekens H. Interchangeability, immunogenicity and biosimilars. Nature Biotechnol (2012) 30:1186–1190.
16. McCamish MC & Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther (2012) 91:405–-417.
17. 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.
18. Pharmtech.com, 30 September 2014. New report details players and pipelines in the biosimilar space. http://www.pharmtech.com/pharmtech/News/New-Report-Details-Players-and-Pipelines-in-the-Bi/ArticleStandard/Article/detail/855810. Accessed 30 January 2015.
19. WebMD. Rheumatoid Arthritis Health Center. Biologics for RA: costs and insurance.  http://www.webmd.com/rheumatoid-arthritis/features/ra-biologics-cost?page=2. Accessed 30 January 2015.
20. Dörner T, Strand V, Castañeda-Hernández G et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis (2013) 72:322–328.
21. National Rheumatoid Arthritis Society, September 2013. Biologics… the story so far. http://www.nras.org.uk/data/files/Publications/Biologics.pdf. 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?