Biosimilars are biological medicines that are highly similar to a pioneering biological product whose patent has expired. They are produced from living organisms, just like the originators, and have comparable efficacy, safety and quality, validated by rigorous clinical and regulatory studies. The development of a biosimilar is usually cheaper, faster and the savings generated can be reallocated to increase the number of patients treated or to fund other areas of the health system.

By reducing the costs of established biological medicines, more can be invested in innovative treatments and new therapies. This strengthens health systems and allows for the sustainability of highly complex treatments, such as immunotherapies and target therapies. With the introduction of biosimilars, there is a capillarization of treatment, because it becomes more feasible to take treatments to previously unattended regions. Patients who previously did not have access to biological therapies, due to cost or logistical reasons, now have more equitable opportunities.

In Brazil, the National Health Surveillance Agency (Anvisa) has regulations in line with international standards, the Unified Health System (SUS) is already using biosimilars in strategic programs and the trend is for an accelerated market growth, driven by both economic needs and public policies to expand access to health.