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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 

Trastuzumab, the first of the HER2-directed therapies, has dramatically improved outcomes for patients with HER2-positive breast cancer and is seen as one of the major success stories in modern oncology. The high cost of trastuzumab 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.

Breast cancer – a major global health issue   +

Breast cancer is the most commonly diagnosed cancer in women worldwide. Despite preventative measures and screening programs, it is also the most common cause of cancer mortality.1 In 2012 alone, there were 1.7 million new cases of breast cancer and over half a million deaths from breast cancer worldwide.1 What’s more, breast cancer is on the rise1 and seems set to remain one of the top causes of female cancer deaths for at least another 15 years.2

The advent of biologics has revolutionized breast cancer care…   +

The ability to identify and target HER2-positive breast cancer, which accounts for 20–25% of all cases, was a major breakthrough in breast cancer management.3 Trastuzumab, the first of the HER2-directed therapies, has dramatically improved outcomes for patients with early* or metastatic disease. It is currently considered standard of care6 and is recommended by clinical guidelines worldwide, including those in Europe and the USA.7,8 And although research into HER2-targeted intervention has rapidly expanded the range of therapeutic options available, trastuzumab remains a central component of most HER2-directed treatment strategies.9,10

* Overall survival at 10 years: 84.0% vs 75.2%; 37% reduction in risk (trastuzumab plus chemo vs chemo alone)4
† Median time to disease progression: 7.4 months vs 4.6 months (trastuzumab plus chemo vs chemo alone)5

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

Unfortunately, many of the world’s cancer patients are not able to reap the benefits of modern research. The reason, of course, is cost. In some developing nations – where a course of trastuzumab can cost more than ten times the average annual wage11 – cancer biologics may be out of reach for virtually the entire population. Even in developed nations, large discrepancies in patient access to biologics exist. For example, clinical oncologists surveyed in Europe and America frequently cite cost as a barrier to prescribing trastuzumab.12 This cost is in addition to that of chemotherapeutics given in combination with trastuzumab,13 as well as the cost of preventing or managing neutropenia secondary to chemotherapy.14 More recently, this cost has risen even further with the approval of another monoclonal antibody, pertuzumab.15,16 For those patients who opt to self-fund, it’s easy to see how a cancer diagnosis can wipe out entire life savings, especially as the costs are often incurred at a time when earning a living may be impossible.17

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."18

USA: "Patients have to pay more for their premiums, more for their copaymments, more for their deductibles. It's become harder to afford what we have, and what we have is becoming not only more costly but also complex."20

WHO: "...the spiralling costs of the cancer burden are damaging the economics of even the richest countries and are way beyond the reach of developing countries."19

India: "...a $15,000 course of trastuzumab can cost more than ten times the average annual wage. And there are no older, off-patient drugs that could serve as an alternative..."21

Patent expiry permits introduction of biosimilars   +

The cost of modern cancer biologics reflects 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.

"Even in the USA, where private medical insurance is predominant, physicians commonly reported 'high out-of-pocket costs for the patient,' trastuzumab 'not being included in the formulary of drugs covered by patients' insurance' or trastuzumab 'not being available in the hospital/clinic where they practice' as barriers to the use of trastuzumab."12

"Because of poor access, patients might recceive suboptimal treatment or interrupted treatment regimens, or might not even benefit from treatment, because of unaafordability and unavailability, thereby decreasing the odds of survival."
Simon Gozar, Chief Executive Officer,
Latin American and Caribbean Society of Medical Oncology 21

There’s no quick-fix solution – but, as some modern cancer biologics start to approach patent expiry, the opportunity arises for new manufacturers to develop more affordable biosimilars. A trastuzumab biosimilar has already been approved in South Korea and plans are in place to launch several more in other countries as soon as possible after expiry of the originator drug patent.22

In late 2016, The Journal of the American Medical Association (JAMA) gave prominence to the findings of the HERITAGE Study reporting that Mylan & Biocon’s candidate trastuzumab biosimilar is clinically equivalent to Herceptin® for the treatment of HER2-positive metastatic breast cancer in combination with a taxane. JAMA’s Editor-in-Chief Howard Bauchner, MD, observed that the study “may influence care for patients with breast cancer around the world,” while Harold J. Burstein, MD, Associate Professor of Medicine at Harvard Medical School, and Deborah Schrag, MD, Associate Editor of JAMA, wrote: “In answer to the proverbial question ‘Would you use the trastuzumab biosimilar for your mother if she had HER2-positive breast cancer?’, the answer should be ‘Yes’.”23–25


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.”

Become a clinical investigator for biosimilars used in breast cancer   +

QuintilesIMS is actively supporting the development of biosimilars for breast cancer 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 trastuzumab 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 breast 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. Rahib L, Smith BD, Aizenberg R et al. Projecting cancer incidence and deaths to 2030: The unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res (2014) 74:2913. 
3. Nahta R & Esteva FJ. HER-2-targeted therapy. Lessons learned and future directions. Clin Cancer Res (2003) 9:5078. 
4. The ASCO Post, 1 March 2013. Final 'joint analysis' confirms life-saving benefit of trastuzumab in patients with HER2-positive early breast cancer. http://www.ascopost.com/issues/march-1,-2013/final-joint-analysis-confirms-life-saving-benefit-of-trastuzumab-in-patients-with-her2-positive-early-breast-cancer.aspx. Accessed 28 January 2015.
5. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med (2001) 344:783–792.
6. Cancer Network. What is the current standard of care for anti-HER2 neoadjuvant therapy in breast cancer? http://www.cancernetwork.com/oncology-journal/what-current-standard-care-anti-her2-neoadjuvant-therapy-breast-cancer. Accessed 28 January 2015.
7. Giordano SH, Temin S, Kirshner J et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. JCO (2014) 32:2078–2099.
8. Cardoso F, Costa A, Norton L et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Breast (2014) 23:489–502. 
9. OncLive.com, 19 December 2014. Frontline T-DM1 results disappointing in Phase III MARIANNE Trial. http://www.onclive.com/web-exclusives/Frontline-T-DM1-Results-Disappointing-in-Phase-III-MARIANNE-Trial. Accessed 28 January 2015.
10. Science Daily, 29 September 2014. Trastuzumab should remain as standard of care for HER2-positive breast cancer, trial suggests. http://www.sciencedaily.com/releases/2014/09/140929105136.htm. Accessed 28 January 2015.
11. Nature, 13 August 2013. India spurns cancer patents. http://www.nature.com/news/india-spurns-cancer-patents-1.13552. Accessed 28 January 2015.
12. Lammers P, Criscitiello C, Curigliano G & Jacobs I. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: A physician survey in the United States and emerging markets. Pharmaceuticals (2014) 7:943–953.
13. Genentech. Herceptin
® prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf. Accessed 28 January 2015.
14. MedScape, 9 January 2015. Neutropenia practice essentials. http://emedicine.medscape.com/article/204821-treatment#aw2aab6b6b4. Accessed 28 January 2015.
15. National Cancer Institute. FDA approval for pertuzumab. http://www.cancer.gov/cancertopics/druginfo/fda-pertuzumab. Accessed 28 January 2015.
16. Genentech. Perjeta
® prescribing information. http://www.gene.com/download/pdf/perjeta_prescribing.pdf. Accessed 28 January 2015.
17. NBC News, 28 April 2014. Breast cancer's costly side-effect: Long-term unemployment. http://www.nbcnews.com/health/cancer/breast-cancers-costly-side-effect-long-term-unemployment-n90016. Accessed 28 January 2015.
18. 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. 
19. World Health Organization, 2013. 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 28 January 2015.
20. USA Today, 27 February 2012. Cancer's growing burden: The high cost of care. http://usatoday30.usatoday.com/news/health/story/health/story/2012-02-27/cancers-growing-burden-the-high-cost-of-care/53271430/1. Accessed 28 January 2015.
21. World Health Organization. Latin American and Caribbean Society of Medical Oncology letter to WHO supporting inclusion of trastuzumab to the essential medicines list. http://www.who.int/selection_medicines/committees/expert/19/applications/SLACOM_Trastuzumab.pdf. Accessed 28 January 2015.
22. GaBI Online, 9 May 2014. Biosimilar trastuzumab candidates in phase III development. http://www.gabionline.net/Biosimilars/Research/Biosimilar-trastuzumab-candidates-in-phase-III-development. Accessed 28 January 2015.
23. Bauchner H, Fontabarosa PB, Golub RM. Scientific evidence and financial obligations to ensure access to biosimilars for cancer treatment. JAMA (2017) 317(1):3334. http://jamanetwork.com/journals/jama/fullarticle/2590049. Accessed 27 March 2017.
24. Burstein HJ and Schrag D.
Biosimilar therapy for ERBB2 (HER2)-positive breast cancer. JAMA (2017) 317(1):3032. http://jamanetwork.com/journals/jama/fullarticle/2590050. Accessed 27 March 2017.
25. Rugo HS, Barve A, Waller CF et al.
Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer. A randomized clinical trial. JAMA (2017) 317(1)37–47. http://jamanetwork.com/journals/jama/fullarticle/2590051. Accessed 27 March 2017.
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