Register Medical Group celebrates a high-impact regulatory achievement for the Brazilian pharmaceutical industry: the approval by the Brazilian Health Regulatory Agency, Anvisa, of two major registration applications for semaglutide-based medicines conducted on behalf of our clients Sun Farmacêutica do Brasil and Ranbaxy Farmacêutica.

The approved products are:

• Orsema®, by Ranbaxy Farmacêutica;
• Seemasun®, by Sun Farmacêutica do Brasil.

The approvals were formalized through Resolution RE No. 2,941, dated July 28, 2026, which granted applications reviewed by Anvisa’s General Office of Medicines.

Orsema® and Seemasun® were registered as new medicinal products containing semaglutide, classified as a new analogous active pharmaceutical ingredient under the abbreviated development pathway. The registrations are listed as valid until August 2036.

A Strategic Achievement for the Brazilian Market

Semaglutide is the same active ingredient found in Ozempic®, a medicine that has achieved significant relevance in the global pharmaceutical market.

Following the expiration of the semaglutide patent in Brazil on March 20, 2026, the industry entered a new phase. This new environment creates opportunities for increased competition, the introduction of additional regulated alternatives, and the continued development of Brazil’s pharmaceutical sector.

Patent expiration, however, does not reduce the regulatory requirements that apply to new products. Before any medicine can be placed on the Brazilian market, it must undergo Anvisa’s review and demonstrate the required standards of quality, safety, and efficacy.

The approval of Orsema® and Seemasun® therefore represents more than the successful completion of two regulatory procedures. It is an achievement connected to a product of major national interest, with the potential to influence competition, innovation, and future access to treatment options.

Understanding the Abbreviated Development Pathway

The regulatory classification of these products deserves careful attention.

Orsema® and Seemasun® were not registered as generic or similar medicines. Anvisa’s official publication classifies them as:

New medicinal products — new analogous API — abbreviated development pathway.

The abbreviated development pathway allows a registration strategy to rely, where permitted, on scientific knowledge and information already established for the active ingredient or therapeutic class.

This does not mean that the products are subject to reduced quality, safety, or efficacy standards.

Applicants must still provide a robust technical and scientific dossier demonstrating that the medicine complies with Anvisa’s applicable requirements. Approval is only granted when the complete set of pharmaceutical, manufacturing, non-clinical, clinical, and regulatory information is considered sufficient by the authority.

Regulatory Success Begins Long Before Submission

A successful drug registration process does not begin when the dossier is submitted.

It starts with the definition of the regulatory strategy, the correct classification of the product, the assessment of technical requirements, the planning of necessary studies, and the early identification of potential risks.

Throughout the project, it is essential to maintain consistency across all sections of the dossier, monitor regulatory timelines, respond appropriately to Anvisa’s requests, and ensure close coordination among all teams involved.

For Register Medical Group, the approvals of Orsema® and Seemasun® reflect a strategy built on four essential pillars.

Strategic Regulatory Planning

Each project requires a clear understanding of the product, its development history, the applicable legal framework, and the most appropriate registration pathway.

A well-defined strategy helps anticipate challenges and reduces the risk of inconsistencies, delays, or avoidable regulatory requirements.

Technical Expertise

Complex pharmaceutical projects require professionals who understand both the regulations and the scientific rationale behind them.

Technical expertise is essential for interpreting Anvisa’s requirements, preparing defensible regulatory positions, and ensuring that the dossier addresses the authority’s expectations.

Documentary Consistency

The quality, manufacturing, clinical, and regulatory sections of a dossier cannot be developed in isolation.

All information must be aligned, technically supported, and presented consistently. Contradictions or gaps between sections may compromise the review and create significant delays.

Close Monitoring Throughout the Process

Submitting the application is only one stage of the regulatory journey.

Continuous monitoring allows the team to follow the progress of the review, identify new developments, prepare responses to regulatory requests, and support the client throughout every phase of the process.

This combination transforms a submission into a structured regulatory project designed to withstand the scrutiny of a highly technical health authority.

A Product of Significant National Interest

Semaglutide has become one of the most closely followed active ingredients in the pharmaceutical and healthcare sectors.

The growing demand for medicines in this therapeutic class has created discussions about supply, competition, access, manufacturing capacity, and the need for additional regulated alternatives.

In this context, the approval of new medicines that have been properly evaluated by Anvisa may contribute to market diversification and the future expansion of available therapeutic options.

Effective access will also depend on manufacturing, distribution, commercial strategy, pricing, and market availability. Nevertheless, obtaining the marketing authorization is an essential milestone that makes all subsequent stages possible.

A Shared Achievement

Register Medical Group congratulates Sun Farmacêutica do Brasil and Ranbaxy Farmacêutica on this important achievement.

We also thank both companies for the trust placed in our team to conduct regulatory projects of such strategic importance to the Brazilian pharmaceutical market.

More than two approvals, this result reflects the combination of technical knowledge, regulatory vision, documentary excellence, and collaboration among teams working toward a common objective.

Register Medical Group remains committed to supporting national and international companies in overcoming complex regulatory challenges and bringing safe, high-quality, and innovative healthcare products to the Brazilian market.

In health regulation, success begins long before submission.

Register Medical Group
Experience makes the difference.