Biosimilar drugs do not penetrate LA as expected

That promise that biosimilar or biocomparable medicines would be an important factor in detonating competition with biotechnological medicines, lowering prices and making them more accessible to a greater number of patients, it is simply time that it is not fully fulfilled, just when the Week is celebrated Global Biosimilars Week. At least not in Latin America where its adoption rate has been rather slow.

Three five years have passed since the approval of the first biosimilars, first in Europe, then in the United States and later in other regions such as Latin America, where they were declared safe and effective alternatives comparable to the reference or innovative product, but they still do not assume the expected role as major players in medical prescription.

It did not happen as with the generic drugs that, when demonstrating that they were bioequivalent quickly, when the patent expired, there was a substitution towards the generic product.

Even so, biosimilars already represent an important market value: At the end of 2020, it is estimated that they reached 17.9 billion dollars (mdd), and for the following decade -by 2030- it is estimated that they will reach a value of 75,000 million dollars. . Regarding the expected savings in health systems globally, IQVIA estimates that they will reach 285 billion dollars (mdd) for the next 5 years.

In Latin America specifically, the reality is that at this point the use of biosimilars -even demonstrating that they are comparable with respect to the reference one- continues to be low and they have not met the expectation in the magnitude that was expected.

In this regard, José Luis Cárdenas, Senior Director of Government Affairs and Access for Latin America at TEVA, comments that for a greater penetration of biosimilars to occur in LA, determined and proactive action by local health systems is required.

Biosimilars today represent perhaps 20 or 30% of biotechnological units. In other words, he specifies that even with a biosimilar available, the region’s health systems continue to use the innovative product in between 80 and 70% of cases. And that has prevented in some way from deepening the benefit of biosimilars.

Another thing that has happened is that there has been a differentiated development. For example, adoption of biosimilar insulins for diabetes has been slow, while oncologics (bevacizumab, rituximab, and trastuzumab) have been adopted more rapidly.

In the Latin American region, biosimilars have been registered in various regions of the world and for different specialties, especially in oncology, and this has helped to lower costs, “but they have not managed to impact health systems, at least not to the extent that one would have expected,” says the interviewee.

What are the reasons for this to have happened?

—First it has to do with the requirements of the comparability studies that biosimilars must carry out in order to be considered as such because they must be comparable with the reference product in terms of safety, efficacy and quality, because this is how they guarantee that they do not have clinically significant differences by the time a patient takes it, which is the most important thing.

Something that has also happened, says Cárdenas, is that in Latin America local regulations have been harmonizing, first largely inspired by the regulations built in Europe, led by the EMA regulator, and later by the US regulator, the FDA. This year, he points out, the WHO approved new guidelines on biosimilars, in an effort to further deepen harmonization.

So, thanks to this harmonization, biosimilar products have been registered in our countries, with Brazil being the country with the most registered products with about 30, followed by Mexico, Colombia and Chile with a smaller number.

According to a count of the Generics and Biosimilars Initiative (GaBI), until 2019 some 23 biosimilars had been authorized for commercialization in the Latin American region; among them are the replicas of the most demanded biotechnological ones such as: bevacizumab (which helps slow the growth and spread of tumors), epoetin alfa (used for anemia caused by chemotherapy), etanercept (used alone or in combination with other drugs to relieve symptoms of autoimmune disorders), filgrastim (used to decrease the risk of infection in people with leukemia), infliximab (used alone or in combination with other drugs for diseases of the immune system), interferon alfa (for chronic myeloid leukemia), and rituximab ( a monoclonal antibody used to treat certain types of cancer and autoimmune diseases).

The GaBI count goes up to 2019, since it is to be expected that during the pandemic the region did not make much progress in this area.

However, what is important is that the different health regulatory authorities in the region, such as the National Administration of Medicines, Food and Medical Technology (ANMAT) in Argentina, the Agência Nacional de VigilânciaSanitária (ANVISA) in Brazil and the Federal Commission for the Protection Contra Riesgos Sanitarios (Cofepris) in Mexico have developed their own abbreviated regulatory pathway for similar biotherapeutic products. And they did it in a way by merging the World Health Organization (WHO) and European Medicines Agency (EMA) biosimilar guidelines to suit their own political and economic needs.

Education, another element that has been missing

Another reason for the low use of biosimilars has to do with education. Cárdenas Tomazic points out that educational campaigns are required both among health professionals, as well as among the patients themselves and in general throughout the health system, about the benefit of biosimilars that they are safe, that they are -as their name indicates – Biocomparable with the innovator, which do not represent significant differences and can be used with absolute confidence.

Initiatives should also arise where the national health systems encourage the knowledge and use of biosimilar medicines in order to close the circle of the biotechnological product. And in this sense, our interviewee uses the case of Germany and Denmark as an example.

—Could you give details about the Danish and German case?

—What they have done is basically aimed at having incentives such as quotas or differentiated payments so that a participation goal for biosimilars can be achieved. In these cases, the health systems make an effort so that the use of biosimilars does not remain at 30%, but rather rises to 50 or 60% of patients; and this can be done with a specific molecule.

Both Germany and Denmark made the decision to promote incentives so that the payment of the biosimilar would be more attractive; and with this they were able to benefit from greater access to biological products. In those countries, it became clear that the impact on the budget is achieved through more active policies that push the system towards a greater use of biosimilars.

This type of action has been lacking in various parts of the world, particularly in Latin America, where it has not been possible to stimulate greater use of these products, and it is a pending challenge in the region.

It’s also a matter of risk.

Another aspect that should be worked on in the region is the predictability of the purchasing system. Because here the development of a biosimilar, unlike a generic, is quite expensive. To produce and register a biosimilar product, it is necessary to invest between 200 and 300 million dollars, especially due to the costs involved in carrying out comparability studies with respect to the reference product. And the problem is that biosimilars reach the market and are rarely used, then the return on the investment that the company makes is very low or different from what was expected, in such a way that this reduces the possibility of a more massive development of biosimilars.

The hope is that the health systems will learn from experiences such as the German and Danish ones, and this dialogue will be generated in search of a greater penetration of the biosimilar because in the end, if there is a greater volume of patients using biosimilars, it will have a positive impact. in the price and, therefore, for the forward system.