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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

For patients with advanced non-small cell lung cancer (NSCLC), the anti-angiogenic biologic bevacizumab can sometimes make a significant clinical difference when added to chemotherapy, including improvements in overall survival. The high cost of bevacizumab currently puts it beyond the reach of many eligible patients – but, as its patent expiry approaches, 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.

Lung cancer – a massive global health issue   +

Despite the positive impact of indoor smoking bans in many countries, lung cancer remains the world’s most common malignancy.1 In China alone (where unprecedented smoking rates and high air pollution are major contributors), 1 million patients with lung cancer are predicted by 2025.2 What’s more, lung cancer is by far the most common global cause of death from cancer.3 Along with preventative measures and earlier diagnosis, the need for improved lung cancer therapy is clearly paramount.
Escalation in NSCLC R&D is a cause for optimism...   +

These are exciting times for clinical oncologists. Research into targeted treatments for the numerous genetic subtypes of non-small cell lung cancer, which accounts for 85% of all lung cancer cases,4 continues to accelerate and the development of novel agents – both small molecules and biologics – is rapidly expanding the therapeutic options available.
...but many patients can't benefit because of the cost   +

However, the reality is that many of the world’s cancer patients are not able to reap the benefits of modern research. The reason of course is cost. Around the world, healthcare authorities and insurers are declining to fund cutting-edge cancer therapies because of their high price tags – and patients who decide to self-fund are frequently faced with a significant financial burden. Even in the Western world, large discrepancies in patient access to biologics exist. In some countries, funding is generally made available but in others, a cancer diagnosis can wipe out entire life savings and sometimes force people to sell their homes, while in some developing countries stark choices may have to be made between medical treatment and basic needs like food and shelter. Sometimes modern treatment is declined because patients are reluctant to leave surviving family members with the burden of an insurmountable debt. It is particularly unfortunate that lung cancer disproportionately affects those least able to afford it.5

The highest prices are for new generation biologics, which can cost in the region of USD $100,000 per patient per year6 and are often not considered a viable option by national reimbursement agencies. Added to this, many patients with lung cancer require another costly biologic (G-CSF) for prevention or management of neutropenia,7 as well as various palliative treatments now widely recommended at an early stage.8

 

UK: "A breast cancer drug that can extend life by almost six months has been turned down for use on the NHS because it is too expensive."9

USA: "I wish it were one-tenth the cost, and if it were I would be giving it to almost everybody"10

WHO: "...the spiralling costs of the cancer burden are damaging the economies of even the richest countries and are way beyond the reach of developing countries"11

"Why can't we have this drug? Anger as cancer medication that saves thousands remain banned"12

Patent expiry permits introduction of biosimilars   +

The prices of novel cancer biologics reflect the scientific innovation and the investment required to support biotechnological research and development. But it puts them 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.

"If we don't figure out a way to make this work for more folks, we are going to end up in a situation where we may have miracles to offer, but no way to pay for them"
J. Leonard Lichtenfeld MD,
Deputy Chief Medical Officer of the American Cancer Society12

There’s no quick-fix solution – but, as some modern NSCLC biologic drugs start to approach patent expiry, the opportunity arises for new manufacturers to develop more affordable biosimilars. In a position paper published by the European Society for Medical Oncology (ESMO) in early 2017, Professor Fortunato Ciardiello, ESMO’s President stated: “Biosimilars are must-have weaponry in financially sustaining healthcare systems on a global scale as well as significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world.”

Biosimilar development in NSCLC   +

The current frontrunner for biosimilar development in advanced/metastatic NSCLC is bevacizumab, an angiogenesis inhibitor (anti-VEGF monoclonal antibody) approved in several countries for colorectal, kidney, breast and ovarian cancers as well as non-squamous NSCLC. Research findings and prevailing consensus are that, while benefit is variable in NSCLC, bevacizumab in combination with platinum-based chemotherapy can sometimes make a significant difference to response rates, progression-free survival and overall survival compared with chemotherapy alone.13,14 Importantly, efficacy of bevacizumab does not depend on the presence of specific genetic mutations and is fairly consistent across different ethnicities.15 Its tolerability is well defined and generally manageable.16 However, cost is the most common reason why clinical oncologists (surveyed in Europe) avoid prescribing bevacizumab.17 As its patent expiry approaches, many biosimilar versions are in development.
Become a bevacizumab biosimilar investigator   +

Quintiles is actively supporting the development of biosimilar versions of bevacizumab in NSCLC 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 the branded biologic or a biosimilar candidate at no cost to them or to their insurers. Even if you perceive that patient access to biologics like bevacizumab 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 of biosimilar clinical trials, gain experience in an area of research projected to expand significantly, and be part of a global mission to bring the benefits of modern cancer treatment to a far wider population.

Learn more about working with QuintilesIMS

References   +

1. World Health Organization 2013. International Agency for Research on Cancer. Press Release no. 223: Latest world cancer statistics. Global cancer burden rises to 14.1 million new cases in 2012: Marked increase in breast cancers must be addressed. http://www.iarc.fr/en/media-centre/pr/2013/pdfs/pr223_E.pdf. Accessed 12 November 2014.
2. South China Morning Post, 17 November 2013. China could have 1 million lung cancer patients by 2025, experts warn. http://www.scmp.com/news/china-insider/article/1358766/china-could-have-1-million-lung-cancer-patients-2025-experts-warn. Accessed 12 November 2014.
3. Chen W, Zheng R, Zeng H, & Zhang S. The epidemiology of lung cancer in China. J Cancer Biol Res (2014) 2:1043.
4. Medscape, 20 October 2014. Non-small cell lung cancer. http://emedicine.medscape.com/article/279960-overview. Accessed 12 November 2014.
5. American Cancer Society, 12 October 2006. Avastin and lung cancer: can we afford miracles? http://www.cancer.org/aboutus/drlensblog/post/2006/10/12/avastin-and-lung-cancercan-we-afford-miracles.aspx. Accessed 12 November 2014.
6. Malik NN. Biologics: Personalized drugs should cut care costs. Nature (2012) 485:582.
7. Kishida  Y, Kawahara M, Teramukai S et al. Chemotherapy-induced neutropenia as a prognostic factor in advanced non-small-cell lung cancer: Results from Japan Multinational Trial Organization LC00-03. Br J Cancer (2009) 101: 1537–1542.
8. ASCO Institute for Quality. ASCO Provisional Clinical Opinion: The integration of palliative care into standard oncology care. http://www.instituteforquality.org/asco-provisional-clinical-opinion-integration-palliative-care-standard-oncology-care. Accessed 30 January 2015.
9. Telegraph, 23 April 2014. Breast cancer drug is too expensive for the NHS: Nice. http://www.telegraph.co.uk/health/healthnews/10779390/Breast-cancer-drug-is-too-expensive-for-the-NHS-Nice.html. Accessed 20 November 2014.
10. New York Times, 15 February 2006. A cancer drug shows promise, at a price that many can’t pay. http://www.nytimes.com/2006/02/15/business/15drug.html?_r=2&. Accessed 20 November 2014.
11. World Health Organization 2014. International Agency for Research on Cancer. Press Release no. 224: Global battle against cancer won’t be won with treatment alone. Effective prevention measures urgently needed to prevent cancer crisis. http://www.iarc.fr/en/media-centre/pr/2014/pdfs/pr224_E.pdf. Accessed 12 November 2014.
12. Daily Mail Online. 24 August 2010. Why can’t we have this drug? Anger as cancer medication that saves thousands remains banned in UK. http://www.dailymail.co.uk/health/article-1305582/Avastin-cancer-drug-banned-NHS.html. Accessed 20 November 2014.
13. Prime Oncology, 29 October 2013. Bevacizumab continues to demonstrate efficacy and safety as a component of front-line therapy for advanced NSCLC, despite a diverse patient population. http://www.primeoncology.org/online_education/solid_tumor/2013/nsclc2013sydney_csp_chinese/nsclc/chinese/enewsflash.aspx. Accessed 12 November 2014.
14. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med (2006) 355:2542–2550.
15. Keating GM. Bevacizumab: a review of its use in advanced cancer. Drugs (2014) 74:1891–1925.
16. Mok TSK, Hsia T-C, Tsai C-M, et al. Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial. Asia–Pacific Journal of Clinical Oncology (2011); 7(Suppl. 2): 4–12.
17. Decision Resources, 17 Devember 2009. Surveyed European oncologists cite cost most frequently as the factor preventing their use of Avastin for non-small-cell lung cancer. http://decisionresources.com/News-and-Events/Press-Releases/NSCLC-Europe-121709. Accessed 12 November 2014.
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