On July 24th, the National Health Surveillance Agency (Anvisa) approved the first generic medication with the substance everolimus, commercially known as Afinitor. The product is indicated for the treatment of several types of cancer, such as advanced breast cancer and kidney cancer, among others. In this way, Natcofarma do Brasil Ltda. was authorized to market the product in the country.

The generic everolimus will be produced by Natco Pharma Limited, based in India. Because it is a generic product, the drug must reach the market with a price at least 35% lower than Afinitor’s maximum price.

Approved indications for everolimus include advanced hormone receptor-positive breast cancer, advanced neuroendocrine tumors, advanced kidney cancer, renal angiomyolipoma (a tumor of the kidney) associated with the Tuberous Sclerosis Complex (TSC) (in patients older than 18 years), and Sega (subependymal giant cell astrocytoma) associated with the TSC.

The Brazilian authorities’ decision comes in a context of biosimilar medicine promotion on behalf of control agencies. In July, the United States Food and Drug Administration (FDA) presented a report that fully details its action plan on biosimilars. The FDA seeks the implementation of new laws aimed at achieving a balance between the innovation of drug development and the incorporation of drugs in a market of free competition.