Biologics Product Registration in Brazil

Entering the Brazilian biopharmaceutical market requires precise regulatory strategy, technical documentation, and local insight. Biologics product registration in Brazil is governed by the Agência Nacional de Vigilância Sanitária (ANVISA), which regulates biologics, biopharmaceuticals, and biosimilars under well-defined frameworks.

At DDReg, we specialize in end-to-end biologics registration services in Brazil, offering regulatory affairs expertise, local representation, and complete lifecycle management to help global life sciences organizations achieve successful market access.

Brazil is the largest pharmaceutical market in Latin America and has one of the most dynamic regulatory frameworks for biologics and biosimilars. The Agência Nacional de Vigilância Sanitária (ANVISA) regulates the registration of these products under Resolution RDC 55/2010, later enhanced by RDC 875/2024, which introduced new reliance and streamlined pathways for biosimilars.

Under ANVISA’s biologics classification:

• A New Biological Product is an innovative biologic active substance not previously registered in Brazil.
• A Biological Product refers to a follow-on version (biosimilar) of an existing biologic registered in Brazil.

The two main regulatory pathways for biological product approval in Brazil include:

• Comparability Pathway – requires extensive comparability data with the reference biologic.
• Individual Development Pathway – allows reduced comparative studies when scientifically justified.

• + Regulatory Strategy & Classification Support
  • Determination of product classification (New Biological or Bisimilar Product)
  • Pathway selection: Comparability vs Individual Development
  • Gap assessment against ANVISA requirements
  • Pre-submission consultation and roadmap preparation
• + Dossier Compilation and Submission (CTD/eCTD)
  • Preparation and localization of full CTD modules (1–5) in Portuguese
  • Data harmonization for comparability, clinical, and quality modules
  • Technical writing and document formatting as per ANVISA eCTD specifications
  • Electronic submission via ANVISA’s portal
• + GMP and Quality Compliance
  • GMP readiness audits and compliance verification
  • Preparation of GMP dossiers and coordination with ANVISA inspectors
  • Liaison for foreign manufacturing site inspection and document validation
• + Biosimilar & Biopharmaceutical Registration Support
  • Comparative analytical and clinical data mapping
  • Development of comparability protocols and justification documents
  • Bridging strategies using international reference products
• + Post-Registration and Lifecycle Management
  • Variations and change control submissions (as per NT 51/2025)
  • Annual reports, renewals, and safety updates
  • Pharmacovigilance setup and compliance alignment
  • Labeling and packaging updates per local requirements
• + Local Regulatory Representation & Communication
  • Acting as ANVISA liaison through Brazilian regulatory partners
  • Document translation and legalization
  • Ongoing authority communication and query management

CPartnering with DDReg gives your organization a regulatory advantage built on science, compliance, and local intelligence. We combine our deep technical expertise in biologics and biosimilars with over 16 years of experience in global regulatory affairs services to streamline your path to ANVIval.

Our team understands the complex interplay between CMC comparability, clinical bridging, and GMP certification that determines biologic product approval in Brazil. With access to regulatory intelligence and local partners in Brazil, DDReg ensures your regulatory submission strategy aligns with the latest RDC guidelines, subject codes, and procedural changes.