Recent FDA and EMA approvals of the anti-angiogenic biologic bevacizumab for relapsed platinum-resistant ovarian cancer in 2014 gave new hope to patients with a bleak prognosis. 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.
Research into targeted treatments for specific genetic subtypes of ovarian cancer is gaining pace but probably the most significant recent development in the field was approval in 2014 from both the FDA and EMA for use of the anti-angiogenic biologic bevacizumab (anti-VEGF monoclonal antibody) in relapsed platinum-resistant ovarian cancer, the most refractory subgroup.3 Based on the results of an international Phase III study – which showed a 62% improvement in progression-free survival with bevacizumab plus chemotherapy versus chemotherapy alone4 – this development represented the first significant therapeutic advance for these hard-to-treat patients since the turn of the century.3 Bevacizumab is also approved in the EU for both treatment-naïve and relapsed, platinum-sensitive ovarian cancer.
Unfortunately many patients with cancer 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.6,7,8 In some developing countries, cancer biologics may be out of reach for virtually the entire population. Even in the Western world, large discrepancies in patient access to biologics exist.9,10
The UK’s National Institute for Health and Care Excellence (NICE) has repeatedly declined to fund bevacizumab on the National Health Service (NHS) for eligible patients with ovarian cancer as well as for other licensed indications such as colorectal cancer and non-small cell lung cancer.11 Similarly, in the USA, bevacizumab is prescribed by oncologists for many cancer types but its cost remains a barrier to patient access.12 A recent survey of US managed care organizations (MCOs) indicated that two-thirds would lower co-insurance charges for bevacizumab if it were less expensive.13
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.
There’s no quick-fix solution – but, as biologic drugs like bevacizumab start to approach patent expiry, the opportunity arises for new manufacturers to develop less costly versions of them, which are most commonly known as biosimilars.*
*also known as follow-on biologics, subsequent-entry biologics and biocomparables, among others
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 originators17,18 – and have resulted in significant cost savings.19
The extent of the testing required means that biosimilars can’t be as heavily discounted as chemical generics. The average saving is projected to be 20–30%,20 but it could well be higher. For a biologic that can cost up to USD $100,0007,21,22 for a year of treatment, these savings are highly worthwhile. In addition, the introduction of competition can 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 Biosimilars, Regulatory Requirements, and Biosimilars by Region.
Bevacizumab is targeted for biosimilar development in a number of indications. Importantly, its efficacy does not depend on the presence of specific genetic mutations and its tolerability is well defined and generally manageable.23,24
QuintilesIMS is actively supporting the development of biosimilar versions of bevacizumab in ovarian 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 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 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 cancer treatment to a far wider population.