Biosimilars: Economic, Health Policy, and Public Health Issues

Dear Colleagues,

The world of biologics is in the spotlight of a new revolution, that of biosimilars, which are “copies” of biological drugs whose patents have expired and which are supposed to lead to similar clinical outcomes as the originators they aim at substituting. As in the case of generics, public and private healthcare payers expect that these products will lead to lower prices in the biologics market and significantly reduce the costs attributable to the therapeutic strategies used to treat severe and disabling diseases such as cancer, chronic inflammatory and rheumatic diseases, diabetes, etc.. Even if they represent a great hope for regulators to achieve significant savings and to fund new therapeutic innovations, for now, the biosimilar market is growing quite heterogeneously across countries. The stakes are particularly high in the field of rheumatology, gastroenterology and oncology. Indeed, in rheumatology and gastroenterology, after the patent expiration of the blockbuster Remicade (infliximab) used in Crohn's disease, ulcerative colitis, and rheumatoid arthritis several years ago in Europe and in the US, it is now the turn of products generating multibillion year expenditures worldwide, commonly used in ambulatory settings, to lose their patents, particularly Humira (adalimumab) and Enbrel (etanercept). In oncology, the European patents of top-selling products commonly used in hospital settings have expired recently: Mabthera (rituximab) indicated for the treatment of certain lymphomas and leukemias, Herceptin (trastuzumab), indicated for the treatment of breast cancer and gastric cancer and Avastin (bevacizumab) indicated in the treatment of colorectal cancer, breast, lung, kidney, ovaries and uterus. The issue of an optimal regulation for biosimilars to ensure both a high public health standard and the efficiency of the system is today at the heart of the debate in all countries: therapeutic equivalence, substitution, interchangeability, price fixing, etc.

While a broad literature exists on biosimilars scientific and clinical development and the quality requirements they have to meet compared to their originators, far less is known about their economic model and, particularly, their real ability to generate competition with other biologics, biosimilars, or innovators in the same therapeutic class. In addition, very few publications provide information about the regulations implemented by legislators and national, regional, federal healthcare authorities across the world and their effectiveness. Finally, the question of the public health impact of introducing biosimilars into the therapeutic arsenal is only rarely analyzed in the literature, in particular the following questions: How are patients who have been switched one or more times between treatments with one or more biosimilars or originators followed up in terms of treatment efficacy and tolerance (different treatment sequences)? How does the healthcare providers organize their procedures both in ambulatory and in hospital settings? How is information provided to patients about the use of these products by physicians and pharmacists in hospitals as well as in ambulatory settings?

The aim of this Special Issue in the International Journal of Environmental Research and Public Health is to try to address all these questions and to make substantial contributions to knowledge gaps in understanding the economic, health policy, and public health issues related to biosimilars.

A wide range of topics will be discussed in this issue, related to, but not limited to, the analysis of the economic model of biosimilars, public or private regulations put in place, policies implemented to frame or encourage their use by doctors and pharmacists (incentives, substitution rules, quotas, etc.) and the results of such initiatives, organizational and public health impact of their arrival into the market worldwide (e.g., switch and follow-up of patients, profiles of treated patients, etc.).   

Topics of interest include but are not limited to:

• What is the economic model of biosimilars and their impact on the market?
• What are the regulations implemented by legislators and national, regional, federal healthcare authorities across the world and their effectiveness?
• What is the public health impact of introducing biosimilars into the therapeutic arsenal (healthcare organizations challenges, patient follow-up, traceability, information to patients)?

Dr. François Bocquet
Guest Editor

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