Anvisa to Rule on Ozempic & Wegovy Alternatives Soon | Weight Loss Drug Updates
- Brazilian health authorities are poised to authorize the sale of alternatives to Novo Nordisk’s popular weight-loss drugs Ozempic and Wegovy, as manufacturers seek to enter the market following...
- Anvisa is currently in the final internal review stages of several applications.
- In December, Anvisa rejected an application from Megalabs for a product containing liraglutide.
Brazilian health authorities are poised to authorize the sale of alternatives to Novo Nordisk’s popular weight-loss drugs Ozempic and Wegovy, as manufacturers seek to enter the market following the expiration of the semaglutide patent on . However, approval is not guaranteed, as the National Health Surveillance Agency (Anvisa) may request additional data or reject applications outright.
Anvisa is currently in the final internal review stages of several applications. One of the medications under evaluation is from EMS, the only Brazilian pharmaceutical company that currently markets weight-loss injections, utilizing liraglutide as its active ingredient – a predecessor to semaglutide found in Saxenda and Victoza. Another advanced application originated with Momenta, a subsidiary of Eurofarma, which has since transferred the process to Ávita Care. Eurofarma already has a presence in the weight-loss market through a partnership with Novo Nordisk for the distribution of Poviztra and Extensior, both semaglutide brands.
In , Anvisa rejected an application from Megalabs for a product containing liraglutide. The agency’s response to inquiries regarding these applications was provided on , following a request made through Brazil’s Access to Information Law (LAI).
These medications are glucagon-like peptide-1 (GLP-1) receptor agonists, hormones produced in the intestine that regulate blood glucose levels and appetite. Currently available brands include semaglutide (Ozempic and Wegovy, from Novo Nordisk) and tirzepatide (Mounjaro, from Lilly), the latter also acting on the GIP hormone receptor and protected by a patent until .
The push to increase access to these medications and lower costs is coming from consumers, industry representatives, and political figures. Increased off-label use for cosmetic purposes, alongside the proliferation of compounded versions of these drugs, is raising concerns among medical associations and societies.
On , the Chamber of Deputies approved an urgent request for a bill to break the patent on products containing tirzepatide, such as Mounjaro. Both the pharmaceutical industry and the government have expressed opposition to this measure.
Anvisa currently has 14 applications for registration of products containing semaglutide and seven for liraglutide. None of these applications are classified as generics, which would require a price at least 35% lower than the reference product. However, market analysts anticipate that increased competition will lead to lower prices.
The Brazilian government, under President Lula, has become directly involved in the market for weight-loss drugs. In , Anvisa prioritized the review of 20 applications for medications containing liraglutide or semaglutide at the request of the Ministry of Health. This action followed a public endorsement of EMS’s newly launched weight-loss injections by Minister Alexandre Padilha.
“Those little pens that people are using all the time, another product in the area, lowering the price for the population,” Minister Padilha stated in a video recorded after an event hosted by the pharmaceutical company.
EMS is well-positioned in the weight-loss market, possessing its own factory for the production of synthetic peptides used in the injections. The company has also received approximately R$736 million in credit from BNDES since for its manufacturing plant.
In a statement, EMS indicated it is awaiting Anvisa’s response regarding its semaglutide products and confirmed that its existing liraglutide-based injections (Lirux and Olire) are widely available.
The government’s acceleration of the review process has drawn criticism from industry groups like Interfarma and Sindusfarma, who cite concerns about legal uncertainty and potential delays in the evaluation of other medications. PróGenéricos, however, argued that the increased demand for these drugs justifies the expedited review.
Anvisa technicians have also expressed reservations, noting in internal documents obtained by Folha that prioritizing weight-loss drugs could delay the approval of therapies for more serious conditions, including cancer, epilepsy, advanced Parkinson’s disease, and spinal muscular atrophy (SMA).
Anvisa maintains that it has established limits on the number of expedited reviews to avoid compromising the evaluation of other therapies and asserts that there was a risk of supply shortages. The agency’s decision also prioritizes products with domestic manufacturing components.
Government officials have also indicated plans to incorporate these treatments into the Unified Health System (SUS), Brazil’s public healthcare system. Initial analyses, however, have ruled out this possibility due to the substantial cost. One potential avenue for providing access through SUS is a partnership between EMS and Fiocruz to transfer the technology for producing the injections to the foundation.