The National Health Surveillance Agency (Anvisa) granted registration to five new drugs that use semaglutide, a substance used in the management of both type 2 diabetes and obesity. This decision, published in the Official Gazette of the Union, aims to increase competition in this segment of the pharmaceutical market.
New Injectable Formulations Receive Authorization
The approval covers five injectable preparations of semaglutide, known as 'weight loss pens.' The measure was formalized this Wednesday, the 29th, and expands the number of licensed companies operating in this niche, especially after the expiration of Novo Nordisk's patent in Brazil. All items maintain the same standard: they are injectable solutions intended for subcutaneous application, supplied with an applicator pen and needles. The registration was obtained under the category of 'new drug (new analogue API) via abbreviated development pathway.'
The newly approved medications include: Zempneo, manufactured by Brainfarma; Semavy, from Cosmed; Orsema, from Ranbaxy; Seemasun, from Sun Farmacêutica; and Owozy, from Ávita Care. They all share a concentration of 1.34 mg/mL and will be sold in 1.5 mL and 3 mL cartridge packages.
Popularity and Mechanism of Semaglutide
Semaglutide gained significant notoriety due to its presence in treatments such as Ozempic, used for type 2 diabetes, and Wegovy, intended for obesity. In addition to helping control glucose levels, this active ingredient has the ability to reduce appetite, which has recently boosted its popularity. Due to high demand, there has been an increase in reports of stock shortages and complaints regarding costs.
However, the Anvisa resolution does not establish deadlines for these new products to reach pharmacies nor does it define their respective prices. The specific therapeutic indications for each medication were also not detailed.
Impact on Market and Patients
This decision comes a few months after the approval of Ozivy, from EMS, which was the first national competitor authorized after the expiration of the semaglutide patent. Because it is a highly complex molecule, these medications undergo an extremely meticulous evaluation process conducted by Anvisa, which checks aspects such as safety, efficacy, quality, immunogenicity, and impurity control before issuing the registration.
The inclusion of new manufacturers should result in an increase in drug supply in the coming years. Nevertheless, it is still premature to predict how this will affect prices or availability in pharmacies. Since semaglutide requires a particular regulatory process, these products are not classified as conventional generics. The next step after the registration approvals is the introduction of these new pens into the market, which will depend on the commercial planning of each manufacturing company.