Measure meets government request and prioritizes products with manufacturing stages in Brazil
Anvisa (National Health Surveillance Agency) decided to accelerate the analysis of the registration of 20 that contain the same active ingredients as medicines such as Ozempic. The decision, according to the newspaper Folha de S.Paulo, was taken after a request from the Ministry of Health with the aim of anticipating the entry of new products into the Brazilian market.
The regulatory agency has defined a schedule to evaluate applications for registration of weight-loss pens based on GLP-1 analogues, a hormone produced in the intestine and linked to glucose and satiety control. Anvisa on requests from EMS, Megalabs and Momenta. In 2026, it will analyze another 14 pens and, in 2027, 3 more.
According to the Sheetthe Ministry of Health formalized the request with the intention of stimulating the national manufacture of these medicines. The justification would be “reduce the country’s technological dependence, strengthening national sovereignty and autonomy”.
In addition to EMS, Megalabs and Momenta, the measure will benefit other pharmaceutical companies such as Biomm, Cristália, Libbs, Aspen, Aché, Althaia, Farma Vision, Ranbaxy, Cosmed, Brainfarma, Dr. Reddy’s, Sun and Cipla. Some of these companies have more than one application under analysis at Anvisa.
The patent for semaglutide will expire in March 2026, while that of tirzepatide (the from Lilly) only expires in 2036. manufacturer of Ozempic, tries to extend the validity of the semaglutide patent.
An initiative to expand access to these medicines is the (Fundação Oswaldo Cruz) to transfer pen production technology to the foundation.
Initially, the production of medicines will be carried out at the EMS factory in Hortolândia (SP) until all production technology is transferred to the Farmanguinhos Medicines Technological Complex, in Rio de Janeiro.
In August, Anvisa published a policy allowing companies to request priority in the evaluation of these medicines, establishing preference for those with components manufactured in Brazil.
The government is also evaluating the possibility of (Sistema Único de Saúde), although initial analyzes prevented this incorporation due to the high costs of medicines.
