Fiocruz and Boehringer sign agreement for generic Jardiance

Brazil’s Institute of Drug Technology (Farmanguinhos/Fiocruz) has announced a partnership agreement with the Brazilian unit of the German family-owned pharma major Boehringer Ingelheim.

This is the first step towards submitting and obtaining registration for a generic product of Jardiance (empagliflozin) 10 mg and 25 mg, with the Brazilian Health Regulatory Agency (Anvisa). The drug is indicated for the treatment of adults with type 2 diabetes mellitus, aimed at improving glycemic control. It is also approved by Anvisa to treat patients with heart failure (HF) to reduce the risk of cardiovascular death and hospitalization, in addition to slowing down the loss of kidney function.

The approval of the generic drug by Anvisa will allow for another treatment option for these diseases in the Unified Health System (SUS), increasing access for the population. This partnership aims to collaborate with the development of the Health Economic-Industrial Complex (HEIC), strengthening the national production of drugs to meet the potential demands of the SUS, Fiocruz noted. Jardiance generated sales of 3.5 billion euros ($3.8 billion) for Boehringer in the first half of 2023.