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Biologics and Biosimilar Regulations and Registration in Brazil

  • According to the Drugs Sector Regulation Chamber (CMED) in 2022, the Brazilian pharmaceutical sector generated US $17.2 billion in sales in 2019.

  • Among rising nations, Brazil has the second-largest market for biologics.

  • A new avenue for regulatory approval of biosimilars was established only in 2010 by Brazil's regulatory body, Agencia Nacional de Vigilancia (ANVISA). However, biosimilar versions of erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF), and insulin have been offered in Brazil since the start of the new millennium.

  • Interestingly, biosimilars made up approximately 20% of biologic prescriptions in Brazil in 2011.

Biologics Biosimilar regulation registration Brazil

This article outlines the regulation and registration of biologics and biosimilar in Brazil ANVISA

In Brazil, the approval process for biosimilar and biologic drugs involves the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária or ANVISA). ANVISA is responsible for regulating and approving these types of drugs to ensure their safety, efficacy, and quality.

"Biosimilar" is the "biological product" registered by comparison pathway even though Brazilian legislation does not adopt the term "biosimilar," but only "new biological products" and "biological products" (for the products that are not new or that contain an already known molecule of a biological nature).

Biologics, also known as reference products, are complex therapeutic products derived from living organisms. They include proteins, peptides, monoclonal antibodies, vaccines, and other products.

Patentability of Biosimilars: If biologic and biosimilar medications meet the criteria for patentability, such as innovation, inventive step, and industrial use, they are typically patentable in Brazil.

Clinical Trial Requirements for Biologics and Biosimilar registration in Brazil (ANVISA):

  1. Pre-Clinical Studies: The drug developer conducts pre-clinical studies, including laboratory tests and animal studies, to gather data on the safety and effectiveness of the biosimilar or biologic drug to qualify for Clinical trials.

  2. Clinical Trials: The drug developer conducts clinical trials in Brazil to evaluate the safety, efficacy, and quality of the drug in humans. These trials typically follow the same phases as traditional pharmaceuticals (Phase I, II, and III trials) and involve different patient populations.

  3. Approval from ANVISA: Before initiating a clinical trial for a biologic or biosimilar in Brazil, the sponsor or investigator must obtain approval from ANVISA. This approval is required to ensure that the trial protocol meets ethical and regulatory standards.

  4. Clinical Trial Protocol: The clinical trial protocol for a biologic or biosimilar should be well-designed and comprehensive. It should outline the study objectives, methodology, inclusion and exclusion criteria, endpoints, treatment regimens, dosing, and safety monitoring procedures.

  5. Comparability Studies for Biosimilars: For biosimilars, comparability studies are a crucial component of clinical trial requirements. These studies aim to establish the similarity between the biosimilar and the reference biologic product in terms of safety and efficacy. Comparability studies typically include assessments of pharmacokinetics, pharmacodynamics, immunogenicity, and clinical endpoints.

  6. Ethics Committee Approval, Patient Safety Monitoring, Good Clinical Practice (GCP) and Data Collection and Reporting are some of the other essential requirements.

Regulatory framework for biologics and biosimilars in Brazil

  1. Biologics Registration: Biologics, which include a wide range of therapeutic products derived from living organisms, are subject to a rigorous registration process in Brazil. The registration dossier for a biologic product typically includes comprehensive data on quality, safety, and efficacy, as well as information on the manufacturing process.

  2. Important Documents:

  • License for Manufacturing

  • Free Sale Certificate/Export Certificate

  • Drug registration and marketing documentary proof in the country of origin

  • Information regarding the registration of drug around the world

  • Pharmacovigilance data

  • CoPP(Certificate of Pharmaceutical Product)

  • GMP Certificate issued by ANVISA

  • GMP Certificate provided by Regulatory Authority in native land

  • Photocopy of GMP certificate in country of origin for imported products

  • Labelling in Portuguese

  • Justification for product registration

  • Local representative sanitary license

  • Samples of finished product

  • And technical details of the product including drug stability, excipients, storage data

  1. Biosimilars Approval Process: Biosimilars are considered similar, but not identical, to an approved reference biologic product. The approval process for biosimilars involves demonstrating a high degree of similarity to the reference product through extensive comparability studies. ANVISA requires evidence of similarity in terms of quality, safety, and efficacy. The level of data required for approval is generally more extensive than for small-molecule generic drugs.

  2. Timelines: About six months after submitting the request for inspection, ANVISA visits the manufacturing facility. Within 45 to 60 days following inspection, ANVISA may give GMP certificates to import medication firms if all requirements are in compliance with Brazilian regulations. Average approval times for pharmaceutical products are 15 to 18 months, and for fixed-dose combos, they are 24 months..

  3. Fees: Official fees range from US $11747.06 to US $31570.98.

  4. Guidelines and Requirements: ANVISA has issued Brazilian regulations under RDC 55/2010 which provide specific guidelines and requirements for the development, registration, and post-approval surveillance of biologics and biosimilars. These guidelines outline the data and studies necessary to demonstrate safety and efficacy, including aspects related to pharmacokinetics, immunogenicity, and clinical trials.

  5. Extrapolation of Indications: ANVISA allows for the extrapolation of indications for biosimilars based on scientific justification. This means that if a biosimilar demonstrates similarity to the reference product in one indication, it may be approved for additional indications without the need for separate clinical trials.

Post-Marketing Surveillance: Once approved, biosimilars are subject to post-marketing surveillance to monitor their safety and effectiveness in real-world use. Manufacturers are required to submit regular safety updates and adverse event reports to ANVISA.

  • Naming and Traceability: Biosimilars are typically assigned distinct names to differentiate them from the reference product. ANVISA has guidelines in place to ensure proper naming and traceability of biosimilars.

  • Adverse Event Reporting: Manufacturers, healthcare professionals, and patients are required to report any adverse events, unexpected side effects, or safety concerns associated with biologics and biosimilars to ANVISA. This information helps identify and assess potential safety issues.

  • Electronic Reporting System: ANVISA has an electronic system in place for the submission of adverse event reports, known as the Sistema de Notificações em Vigilância Sanitária (NOTIVISA). This system allows for efficient and standardized reporting of adverse events.

  • Signal Detection and Analysis: ANVISA actively monitors the reported adverse events and conducts signal detection and analysis to identify potential safety signals or patterns that may require further investigation.

  • Risk Management and Assessment: ANVISA assesses the risks associated with biologics and biosimilars based on the reported adverse events and available data. This assessment may lead to regulatory actions such as safety communications, labeling updates, or changes to the product's risk management plan.

  • Communication with Stakeholders: ANVISA communicates safety-related information to healthcare professionals, patients, and the public to ensure awareness of any emerging safety concerns or updates.

  • Inspections and Audits: ANVISA may conduct inspections or audits of manufacturers and their pharmacovigilance systems to ensure compliance with post-marketing surveillance requirements and proper handling of adverse event reports.

  • Labeling Updates: Based on the findings of post-marketing surveillance, ANVISA may require manufacturers to update product labeling with new safety information, warnings, precautions, or contraindications.

  • Collaboration with International Authorities: ANVISA collaborates with other regulatory agencies and international organizations to share safety information and stay informed about global pharmacovigilance trends.

  • Periodic Safety Updates: Manufacturers are required to provide periodic safety update reports to ANVISA, which summarize safety data and any actions taken to address safety concerns.

  • Public Consultations: ANVISA may initiate public consultations or advisory committees to discuss safety-related matters and gather input from healthcare professionals, patients, and other stakeholders.



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