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.
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.5The 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
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 some modern NSCLC biologic drugs 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 to 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 originators13,14 – and have resulted in significant cost savings.15The 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%,16 but it could well be higher. For a $100,000/year cancer medication, this is a highly worthwhile saving. 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.
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.