Biosimilars and the sustainability of the healthcare system

Author: José Luis Cardenas, Sr. Director Government & Access Teva LatAm.?(Published in “El Economista")

“Sixteen years have already passed since the approval of the first biosimilars in the European Union, which was the starting point of this story, which is still just beginning. Today, more than 80 biosimilars have been approved. Today, biosimilars are a reality worldwide and are changing the lives of millions of patients, which is what is relevant. Therefore, it is important to recapitulate their journey to understand where we have come from and where we are going, especially on the eve of Global Biosimilars Week, which will be held between November 14 and 18 this year.

In order to talk about biosimilars, we must first conceptualize what biopharmaceuticals or biotherapeutics are.

The term "biopharmaceutical" was coined in the 1980s and refers to pharmaceutical products produced in biotechnological processes with highly sophisticated and expensive molecular biology methods, whose investment in research and development ranges from 1,000 to 2,000 million dollars. These are manufactured from living cells, as opposed to synthetic drugs, which are products of chemical processes.

Biopharmaceuticals have created enormous advances in recent decades for the treatment of diseases such as cancer, rheumatoid arthritis, as well as other autoimmune diseases and diabetes mellitus, among others, and have been positively received by health systems, but not for their economic impact: the annual cost per patient is in the range of 10,000-50,000 dollars. In many countries, spending on biopharmaceuticals represents more than 40% of the total drug budget.

This is the context for biosimilars, which have been defined by the World Health Organization (WHO) as biological products that have been shown to be highly similar in terms of safety and efficacy to an already authorized reference product, which is the innovator, which made the investment in research and development and which is protected by patents or other mechanisms; once expired, the biopharmaceutical-innovator drug can be legitimately replicated by a third party, through the development of a biosimilar. These alternatives do not require investment in studies to demonstrate the safety and efficacy of the drug itself, which has already been done for the innovator drug, but rather in those that robustly prove to be highly similar to the innovator drug. The consulting firm McKinsey estimates that the cost for the development of a biosimilar is between 100 and 300 million dollars.

Biosimilars generate competition to the innovative or reference drug, allowing lower costs, improving access, to the benefit of patients suffering from complex diseases that reduce life expectancy or the quality of life.

However, for this promise to be realized and for savings and access to be generated, biosimilars must be properly approved by the regulatory authorities, but they must also be used by healthcare professionals, accepted by patients and purchased by healthcare systems.

With regard to the requirements for approval, the European Union was the pioneer in establishing a specific procedure for biosimilars in 2005. The WHO approved guidelines only in 2009, as did South Korea, Japan and Singapore, and Canada and the United States in 2010. Subsequently, more than 22 countries have followed suit, on different continents.

In 2019, the WHO, in view of all the scientific progress achieved during the decade and a half of experience with biosimilars, considered that a more tailored and potentially reduced clinical data package could be acceptable in cases where it is clearly supported by the available scientific evidence, where the fundamental concept is to have the totality of evidence. This led the WHO to publish, in the middle of this year, new guidelines on the evaluation of biosimilars, which seeks greater harmonization of regulations worldwide, facilitating their development, in line with the progress of science.

Well, as anticipated, it is not enough for biosimilars to be approved. There are countries where, once a biosimilar is approved, it generally reaches a market share of between 60% and 90%, such as Germany, Denmark, Spain, France, Holland, Italy, Norway and the United Kingdom. In other countries, such as the United States of America or Japan, as well as in some Latin American countries, the penetration of biosimilars is much lower, below 30%.

In this sense, education about biosimilars is crucial, aimed at both healthcare professionals and patients. Without proper understanding and confidence, their use will remain low. In addition, the different regulatory models on safe interchangeability between the innovator product and the biosimilar; the switch, which is the physician's decision to switch the patient to the biosimilar; and substitution, which occurs at the pharmacy level, play a fundamental role in their level of use. Thus, on September 19, 2022, the European Medicines Agency (EMA), together with the agencies of the European Economic Area, issued a statement reaffirming that biosimilars approved by the European Union are interchangeable, i.e., the possibility of changing one drug for another that is expected to have the same clinical effect.

Another determining factor is the involvement of payers or funders, encouraging the use of biosimilars.

As can be seen, in these 16 years of history, much progress has been made, but there is still a long way to go in terms of use and understanding of biosimilars. The key is to learn from successful cases and try to adapt good practices to those countries where the results have been modest. This will not only make healthcare systems more economically sustainable, but will also allow a greater number of patients to benefit from the advances of biopharmaceuticals.”