For years, the costs of drugs have been rising. Prescription drug spending in the US rose by 12.6% in 2014 and almost 1 in 4 Americans report difficulty affording their prescriptions. A familiar situation in many countries, the escalating costs of drugs make them unaffordable for a large part of the world.
One means of reducing costs is to use biosimilars, drugs that are almost identical to the brand-name versions and can be manufactured when the originator product’s patent expires. These drugs are designed to have very similar activity to a previously licensed compound but can be much more affordable.
In 2013, the global biosimilars market was estimated at over US$1.3 billion [1]; a figure which is predicted to almost triple by 2020 as the patents of several blockbuster drugs expire. As the market for biosimilars grows, clinicians, regulators and pharmaceutical companies are starting to take note.
Although they clearly have great potential, biosimilars have suffered from problems with public perception. This is because, unlike small molecule generics, it is impossible to create an exact replica of a biological (drugs made from living cells). Biologicals are complex to manufacture and small changes to the production process can change the properties of the medication. This has led some companies to argue that biosimilars, while more cost-effective than originator brand-name drugs, cannot be considered interchangeable.
A new study may help to put these concerns to rest, by showing that medications can be just as effective even when manufactured by a different company. The study, from international authority on health improvement the John Hopkins Bloomberg School of Public Health, suggests that biosimilars are just as good as their reference compounds, using tumour necrosis factor (TNF) inhibitors as a case study [2].
TNF inhibitors block the activity of a protein involved in inflammation, and were the first biological therapies for rheumatoid arthritis. Today, these drugs are used for a wide range of disorders caused by an overactive immune system. This study, published in the Annals of Internal Medicine in August 2016, focused on TNF-α inhibitors, which are used to treat conditions including rheumatoid arthritis, inflammatory bowel disease and the skin disorder psoriasis.
The researchers looked at 19 studies that compared originator and biosimilar versions of the drugs. They collected the evidence from a range of sources, including the European Medicines Agency, US Food and Drug Administration and World Health Organization.
The studies included randomized clinical trials in phase I – the first stage of testing in humans – and phase III – larger trials designed to assess the effectiveness of drugs. All of the phase I trials confirmed that the biosimilars were bioequivalent to their respective biologicals, while the later phase III trials showed that the drugs also had similar clinical efficacy. Observational studies of people who switched from reference TNF-α inhibitors to biosimilars showed that they were both safe and similarly effective.
While the authors acknowledge that some of the studies were small and they only analysed a limited number, they say their findings support the similarity of reference and biosimilar TNF-α inhibitors, so much so that they say the drugs could be used interchangeably. These findings should reassure both patients and clinicians that biosimilars, at least for TNF-α inhibitors, are comparable to their brand-name equivalents. The authors hope their work will encourage the acceptance and adoption of the drugs, which could massively reduce healthcare costs.
Only one TNF-α inhibitor biosimilar has so far been approved in the US (Inflectra, a biosimilar infliximab of originator Remicade), although several have been approved in Europe. The study comes at an opportune time for the biosimilars market, as several biological drugs have patents soon to expire.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Evolution of biosimilars in developed and developing countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/Research/Evolution-of-biosimilars-in-developed-and-developing-countries
2. Chingcuanco F, Segal J, Kim S, Alexander G. Bioequivalence of biosimilar tumor necrosis factor-α inhibitors compared with their reference biologics. Ann Intern Med. 2016 Aug 2. doi: 10.7326/M16-0428. [Epub ahead of print]
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