LAUSR

The clinical development and use of biologic agents, or biologics, has successfully improved outcomes in several lifethreatening diseases, including malignancies. In cancer medicine, the development of biologics has significantly expanded the availability of valuable options of treatments for the curable and advanced setting, along with indications of supportive care to control treatment-related toxicities [1]. However, the cost of biologics used in oncology represents one major barrier to the global uptake of cancer treatments, resulting in disparities in the affordable access to therapy for patients, especially in but not limited to low-middle income countries (LMIC), implying large survival gaps in the world. With the expiration of the patents of biological agents, room for affordable and sustainable production has been pushed, and several industries have established programs of biosimilar development. The relevance of biosimilars is to drive the development of sustainable cancer programs in LMIC, as envisioned by the World Health Organization (WHO), endorsing their value to enhance the pharmacological development and clinical uptake of biosimilars as functional to the commitment of improving the affordable access to essential medicines for patients with cancer [2]. In 2019, WHO included the biosimilars of the essential medicines rituximab and trastuzumab in the WHO essential list of medicines (EML), integrating the previous mention of the biosimilars of erythropoietin agents and of filgrastim. The EML Secretariat recognized the value of biosimilars as therapeutically equivalent alternatives capable of leading greater market competition, improved patient access and reduced costs for health systems. Stating the interchangeability of biosimilar products as a very important rule for wider access and a crucial aspect to foster competition [3]. The WHO Committee considered that where biosimilars of listed essential medicines exist, these must also be considered therapeutically equivalent for procurement purposes – tackling a key issue in the selection of medicines. The uptake of biosimilars is included among the strategies to improve efficiency in health systems, pertaining resource selection and utilization, expected to reduce waste of resources and improve the costeffectiveness of medical interventions. 2. Facts and perspectives in biosimilars for breast cancer