(FOLHAPRESS) - Anvisa (National Health Surveillance Agency) approved the country's first generic semaglutide medicine, which will be manufactured by the pharmaceutical company EMS, owner of Ozivy. The decision was taken last Thursday (13) and published in the Official Gazette of the Union this Monday (17).
Anvisa approves the country's first semaglutide generic
(FOLHAPRESS) - Anvisa (National Health Surveillance Agency) approved the country's first generic semaglutide medicine, which will be manufactured by the pharmaceutical company EMS, owner of Ozivy. The decision was taken last Thursday (13)...
In practice, the new approval creates a second EMS product based on semaglutide, now included in the generic category. The registration includes four presentations, with a 1.34 mg/mL solution in 1.5 mL or 3 mL pens.
- The generic pen does not have a commercial name, as determined by the regulations for generic medicines.
- Still, the new EMS registration is linked to the process that gave rise to Ozivy.
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In practice, the new approval creates a second EMS product based on semaglutide, now included in the generic category. The registration includes four presentations, with a 1.34 mg/mL solution in 1.5 mL or 3 mL pens.
The generic pen does not have a commercial name, as determined by the regulations for generic medicines. Still, the new EMS registration is linked to the process that gave rise to Ozivy.
Semaglutide medications belong to the class of GLP-1 analogues, that is, they act in a similar way to the natural hormone. They modulate natural satiety and metabolic regulation mechanisms, contributing to weight loss.
Tirzepatide, the active ingredient in Mounjaro, acts on two hormones: GLP-1 and GIP. Therefore, it is called a double agonist. Therefore, tirzepatide is called a double agonist, but this does not mean that it is simply stronger.
Ozivy was the first product containing semaglutide approved by Anvisa since the substance lost its patent on March 20. The exclusivity in the manufacture of medicines containing this active ingredient (Ozempic and Wegovy) belonged to the pharmaceutical company Novo Nordisk.
On July 10, Anvisa included Ozivy on the Reference Medicines List (LMR). As a result, the medicine became considered a parameter of efficacy, safety and quality for other medicines based on synthetic semaglutide, generic or similar, being developed in the country.
Generic medicines contain the same active ingredient, in the same dose and pharmaceutical form, which requires demonstration of equivalence in relation to the reference medicine.
Under Brazilian legislation, the price of the generic must be at least 35% lower than that of the reference medicine. In the case of Ozivy, EMS announced prices between R$452 and R$498 per pen when the product arrived in pharmacies in June. Applying this calculation, the generic can cost between R$293 and R$323.
The competitor Ozempic, from Novo Nordisk, costs from R$ 975 - through the NovoDia Price program (e-commerce) in the 0.25 mg and 0.5 mg versions - to R$ 999 for the 1 mg dosage.
Anvisa also registered this Monday a drug from Germed, called Semaclique, in the similar drug category, with semaglutide at a concentration of 1.34 mg/mL.
Similar medicines are identified by brand or trade name. And, unlike generic medicines, not every similar medicine can be exchanged for the reference medicine, according to Anvisa.*QUESTIONS AND ANSWERS ABOUT SEMAGLUTIDE
- What is semaglutide? Semaglutide is the active ingredient in medicines such as Ozempic and Wegovy.
It imitates the action of GLP-1, a hormone naturally produced by the body that participates in the control of glucose and satiety.
By activating GLP-1 receptors, the substance helps control blood glucose, reduces appetite and increases the feeling of satiety, which can contribute to weight loss.
Tirzepatide (active ingredient in Mounjaro) acts on two hormones: GLP-1 and GIP. Therefore, it is called a double agonist.
- What is Ozivy?
It is a semaglutide-based medicine produced by the pharmaceutical company EMS. It was the first product of its kind approved by Anvisa after the end of the semaglutide patent in Brazil, in March.
The medicine is classified as a new medicine, not a generic. The indication is for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise.
The product is presented as an injectable solution, in a pre-filled pen for weekly administration.
- Is the new generic already on sale?
No. Although Anvisa has granted registration, the medicine still needs to go through other steps before reaching pharmacies, including price definition by CMED (Chamber of Medicines Market Regulation).
- How much will the generic cost?
The price of the new generic has not yet been defined.
Under Brazilian legislation, generic medicines must reach the market with a price at least 35% lower than the reference medicine.
The amount actually charged in pharmacies, however, may vary.
- What is a generic medicine?
It is a medicine that contains the same active ingredient, in the same dose and pharmaceutical form and through the same route of administration as the reference medicine.
To receive registration, you need to demonstrate equivalence in relation to the reference product. The generic does not have a commercial brand: the name of the active ingredient appears on the packaging.
- What changes for those who use Ozempic?
The approval of new semaglutide medications expands the number of products available on the market and may increase competition. This, however, does not mean that a product can be This, however, does not mean that one product can be replaced by another. replaced by another.
Interchangeability depends on the regulatory category and tests presented to Anvisa.
- What is the difference between generic and similar?
Both need to demonstrate quality, safety and efficacy to Anvisa, but there are differences in the way they are sold. The generic does not have a trademark, while the similar one is identified by a brand or commercial name.
The generic can be interchangeable with the reference medicine when it meets regulatory requirements. A similar product can only be replaced by the reference medicine when it is classified as interchangeable by Anvisa.
As a rule, a generic and a similar cannot be directly exchanged for each other.
Slimming pens could have a new effect on your face, doctors say
Doctors report loss of volume on the sides of the face among patients who lost weight quickly using GLP-1 class drugs. Change is not exclusive to pens and can occur after any sharp reduction