Biologics such as the TNF-alpha inhibitors (which include adalimumab, etanercept, and infliximab) have revolutionized psoriasis care, significantly brightening the outlook for the global population affected by this disfiguring and potentially debilitating disease. The high cost of biologics currently puts them beyond the reach of many eligible patients – but, as some modern 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.
Unfortunately many patients with psoriasis 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 TNF-alpha inhibitors for conditions like psoriasis may be out of reach for virtually the entire population.12 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 TNF-alpha inhibitors is often unsustainable, with many patients denied them.13,14 For example, in more than 50% of European countries, the annual cost of a TNF-alpha inhibitor can exceed the per capita gross domestic product (GDP) by as much as 11 times, meaning that access is severely restricted in almost 40% of the total European population.13 In the USA, lack of reimbursement by insurers is one of the main reasons why patients with psoriasis discontinue biologic treatment even when it has been of significant help to them.15
There’s no quick-fix solution – but, as some modern biologics used for psoriasis start to approach patent expiry, the opportunity arises for new manufacturers to develop less costly versions, which are most commonly known as biosimilars.* Infliximab biosimilars 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 is also in progress.
*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 have been launched in Europe with no adverse clinical consequences compared with their originators19, 20 – and have resulted in significant cost savings.21
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%,22 but they could well be higher. For a biologic that typically costs USD $10,000 to $30,00023 per patient per year, these savings are highly worthwhile, especially as some patients with psoriasis may require lifelong treatment.24,25 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.
Quintiles is actively supporting the development of biosimilars for psoriasis 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 psoriasis 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 psoriasis treatment to a far wider population.