Agência Nacional of Vigilância Sanitária authorized the registration of the drug Ozivy, marking the entry of the first synthetic semaglutide pen into the national market. The decision took place on Tuesday, May 26, and represents an important regulatory milestone for the treatment of patients. The product works in a similar way to the well-known Ozempic, which had its patent expired in March this year. Release was granted to the EMS/SA laboratory after rigorous analysis.
The approval process required detailed proof of the efficacy, safety and quality of the pharmaceutical product. The initial request reached the agency in 2023 and followed the order of priority established in specific notices for drugs in the GLP-1 class. Brasil emerges as one of the first countries to authorize this category of synthetic treatment. Atualmente, other similar processes await technical evaluation in the regulatory agency queues.
Indicações clinics and use in glycemic control
The new drug is directly indicated for the treatment of adults diagnosed with type 2 diabetes mellitus who have insufficient glycemic control. The application should function as an adjuvant treatment, always associated with lifestyle changes, including a balanced diet and regular physical exercise. Profissionais Health highlights the importance of this combined approach. Medication does not replace the healthy habits necessary to control chronic disease.
In terms of prescription, the product can be used in monotherapy format in cases where the patient has intolerance or contraindications to the use of metformin. The substance also allows association with other medications already used to control diabetes. Therapeutic flexibility helps doctors personalize treatment. Como occurs with all drugs in the GLP-1 class, acquisition in pharmacies will require the presentation of a medical prescription in two copies.
Formatos presentation and available dosages
The responsible pharmaceutical industry will make the treatment available in injectable solution format, using pre-filled pens designed for weekly administration. The design of the device seeks to facilitate self-application by patients in the home environment. The regulatory agency has approved different packaging configurations to meet the varying dosage needs and treatment time prescribed by experts.
The options authorized for commercialization in the national territory include the following presentations:
- Solução injectable semaglutide 1.34 mg/mL with 1.5 ml containing a pen and six needles
- Solução injectable semaglutide 1.34 mg/mL with 3 ml containing two pens and ten needles
- Solução injectable semaglutide 1.34 mg/mL with 1.5 ml containing a pen and four needles
- Solução injectable semaglutide 1.34 mg/mL with 3 ml containing two pens and eight needles
The variety of presentations allows the patient to acquire the exact amount recommended for their therapeutic cycle. Continuous medical monitoring remains essential to adjust doses as the clinical condition evolves. The correct use of disposable needles guarantees the safety and effectiveness of each weekly application.
Regras strict thermal storage and conservation
One of the most significant differences between the new synthetic product and the traditional biological version lies in the thermal conservation requirements. The Ozivy requires continuous storage in a refrigerator, with strictly controlled temperatures between 2°C and 8°C. Essa refrigeration rule applies both to the period prior to use and throughout the course of treatment. The patient needs to keep the pen refrigerated even after the first application.
The reference medicine, on the other hand, has more flexible rules after the initial seal is broken. The biological version requires refrigeration only before first use, withstanding ambient temperatures of up to 30°C for a period of six weeks. Essa practical distinction requires extra attention from new users. Farmacêuticos will need to educate consumers on the importance of not interrupting the synthetic product’s cold chain at any time.
The variation in temperature requirements directly reflects the structural characteristics of each formulation. Synthetic analogues result from chemical synthesis processes, generating smaller, highly stable molecules under specific conditions. Biological medicines involve complex molecules obtained through living pharmaceutical ingredients or advanced biotechnological procedures with recombinant DNA. The nature of manufacturing dictates the behavior of the product in the external environment.
Complexidade technique in the evaluation of synthetic analogues
The analysis and release of synthetic semaglutide analogues represent a highly complex technical challenge for health authorities on a global scale. Antes of this recent approval, all medicines based on this substance authorized in the country belonged to the biological category. The structural and functional integrity of these complex molecules usually requires the injectable route as the standard of administration. The regulatory scenario needed to adapt to this new technological reality.
Products generated by chemical synthesis open the door to different routes of administration in the future, including oral, inhalation and ophthalmic formats. However, safety assessment requires extreme scientific rigor. Esses items share characteristics inherent to synthetic medicines, such as the possible presence of residues of solvents and metal catalysts arising from manufacturing. Laboratory analysis needs to rule out any risk of accumulated toxicity.
At the same time, these formulations maintain behaviors typical of biological agents within the human organism. Evaluators need to closely monitor the risk of immunogenicity, which occurs when the body develops antibodies against the treatment. The possibility of molecular aggregate formation also requires extensive testing before commercial release. The Brazilian agency demonstrated advanced technical capacity by completing this process in a pioneering way.
Final Etapas for commercialization and public access
Apesar sanitary release, the product will not immediately reach the shelves of Brazilian pharmacies. The item received the official classification of a new medicine, representing a synthetic analogue of an existing biological product. Current legislation does not allow classification as a generic medicine, as this category does not apply to biological formulations in the national regulatory framework. The legal distinction directly impacts the next bureaucratic steps.
The start of sales now depends on the approval of the maximum consumer price. Câmara of Regulação of Mercado of Medicamentos will conduct this financial analysis based on economic criteria and international comparisons. Somente after publication of the price ceiling in the official journal, the company holding the registration will be able to define the launch strategy and the exact distribution date. The retail sector is awaiting this definition to organize refrigerated stocks.
Free access through Sistema Único from Saúde will require an independent and careful administrative path. Comissão Nacional of Incorporação of Tecnologias in the SUS will need to evaluate the cost-effectiveness of the treatment in comparison with the options already available in the public network. Ministério of Saúde will make the final decision based on this technical opinion. Historicamente, not all innovations approved by health surveillance are financially viable for immediate universal distribution.