May 13, 2017 Volume 389 Number 10082 p1859-1952
Improving access to biosimilars in low-income countries
Published: 13 May 2017
From September, 2017, WHO will accept applications for prequalification into their Essential Medicines List for biosimilar versions of two biologics: rituximab (for non-Hodgkin’s lymphoma) and trastuzumab (for breast cancer). This pilot project is an effort to increase access to these costly cancer treatments in low-income countries.
Biologics are medicines, usually antibodies, produced from living sources such as cells and blood, increasingly used to treat cancer as well as inflammatory diseases, such as arthritis and asthma. When patents for biologics expire, manufacturers can make biosimilar versions of the product with the same biological effect and characteristics as the original. Because their source is biological or living, one concern is that slight variations in manufacturing processes could alter the biosimilar.
The WHO Prequalification of Medicines Programme ensures that medicines purchased by international procurement agencies (eg, UNICEF) for distribution in low-income countries meet acceptable standards of quality, safety, and efficacy. The Lancet Commission on Essential Medicines recommended that the prequalification programme should expand the range of essential medicines, including biosimilars. With this welcome expansion, however, rigorous guidance and regulation for quality assurance will be required by WHO.
The incentive for governments to embrace biosimilars is to lower costs, which in turn should increase access and improve population health-care outcomes. However, the advent of biosimilars has not yet reduced costs as one might have expected from the generic drug experience. This might be because list prices for biosimilars are often not much cheaper, at around 70–85% of the list price of the original product; by contrast, generic drugs are usually markedly cheaper (20% of the originator’s price). Development of biosimilars is more costly and takes longer than for small-molecule generics. That said, countries such as Norway have achieved large price cuts by switching almost entirely to biosimilar versions and effectively tendering these switches. WHO prequalification will hopefully increase competition in the biosimilar market to further reduce the price and increase access to these medicines in low-income countries.