Navigating The Brazilian Market With RDC 875/2024: How Maven Supports Your Biosimilars Journey

Introduction: A New Regulatory Era for Biosimilars in Brazil

Brazil has taken a significant step forward in advancing biosimilar accessibility with the introduction of Resolution RDC No. 875/2024, updating the regulatory framework previously established under RDC 55/2010. This regulatory evolution, implemented by ANVISA, reflects Brazil’s commitment to fostering innovation, improving patient access to biologics, and aligning with global biosimilar regulatory standards.

The updated framework introduces greater flexibility in biosimilar registration pathways, reduces unnecessary regulatory burdens, and promotes a science-based approach while maintaining stringent requirements for quality, safety, and efficacy.

For organizations targeting the Brazilian market, navigating RDC 875/2024 requires deep expertise in biosimilar development, comparability assessment, regulatory strategy, and ANVISA submission processes.

Maven Regulatory Solutions provides comprehensive support across the biosimilar’s lifecycle, enabling companies to accelerate approvals and achieve successful market entry in Brazil.

Overview of RDC 875/2024: Key Regulatory Objectives

RDC 875/2024 is designed to:

• Streamline biosimilar registration pathways 
• Encourage market competition and affordability 
• Enable global alignment with biosimilar guidelines 
• Reduce duplication of clinical and non-clinical studies 
• Strengthening scientific comparability approaches 

Key Changes Introduced Under RDC 875/2024

1. Enhanced Comparability Pathway for Biosimilars

The comparability pathway remains the cornerstone of biosimilar approval in Brazil.

Key Requirements:

• Analytical characterization of the molecule 
• Comparative quality data 
• Pharmacokinetic (PK) and Pharmacodynamic (PD) studies 
• Immunogenicity assessment 

This pathway allows sponsors to demonstrate that the biosimilar is highly similar to the reference biological product, reducing the need for full-scale clinical development.

2. Acceptance of International Reference Products

A major regulatory advancement under RDC 875/2024 is the allowance for international reference biologics when local reference products are unavailable.

Impact:

• Facilitates global development strategies 
• Reduce barriers for multinational biosimilar developers 
• Supports bridging studies using internationally approved products 

3. Flexibility in Non-Clinical and Clinical Requirements

RDC 875/2024 introduces a risk-based approach to waive certain studies.

Key Highlights:

• Potential waiver of non-clinical studies 
• Reduced requirement for comparative clinical trials 
• Increased reliance on in vitro and analytical characterization data 

This significantly reduces development timelines and costs, while maintaining scientific rigor.

Comparison of RDC 55/2010 vs RDC 875/2024

4. Strengthened Stakeholder Engagement

The development of RDC 875/2024 involved extensive collaboration between regulators and industry stakeholders through:

• Public consultations 
• Sector dialogues 
• Regulatory impact assessments 

This ensures a balanced framework that supports both innovation and compliance.

Regulatory Requirements for Biosimilar Approval in Brazil

To obtain approval under RDC 875/2024, sponsors must submit a comprehensive dossier to ANVISA including:

• Quality (CMC) data 
• Comparability studies 
• Non-clinical and clinical data (if required) 
• Risk management plans (RMP) 
• Pharmacovigilance strategy 

Core Dossier Components for Biosimilars

Latest Trends in Biosimilar Regulations

• Increased reliance on analytical comparability and advanced characterization techniques 
• Global convergence with EMA and WHO biosimilar guidelines
• Adoption of real-world evidence (RWE) in regulatory decision-making 
• Expansion of digital regulatory submissions (eCTD) 
• Focus on cost reduction and accelerated approvals for biologics 

Maven Regulatory Solutions: Accelerating Your Biosimilars Journey in Brazil

Maven Regulatory Solutions delivers end-to-end biosimilar regulatory support, ensuring compliance with RDC 875/2024 and successful product registration.

1. Regulatory Strategy & Pathway Optimization

• Tailored biosimilar development strategies 
• Gap analysis for RDC 875/2024 compliance 
• Global-to-local regulatory alignment 

2. Dossier Preparation & Technical Documentation

• CTD/eCTD dossier compilation 
• Analytical and comparability data integration 
• Scientific writing and regulatory justification 

3. ANVISA Submission & Regulatory Interactions

• End-to-end submission management 
• Response to deficiency letters 
• Agency meeting preparation 

4. Clinical & Non-Clinical Strategy Support

• Study design optimization 
• Waiver justification for clinical/non-clinical data 
• PK/PD study planning 

5. Market Access & Lifecycle Management

• Regulatory intelligence for Brazil 
• Post-approval compliance and variations 
• Pharmacovigilance system implementation 

Maven Biosimilars Capabilities

Opportunities for Biosimilar Developers in Brazil

RDC 875/2024 opens new opportunities for:

• Faster biosimilar approvals and reduced development costs
• Expansion into Latin American pharmaceutical markets 
• Increased competition and accessibility of biologics 
• Strategic alignment with global biosimilar development programs 

Conclusion

The introduction of RDC 875/2024 represents a transformative shift in Brazil’s biosimilar regulatory framework, offering enhanced flexibility while maintaining high standards of safety and efficacy.

For pharmaceutical companies, success in this evolving landscape depends on a strategic, science-driven, and compliant approach to biosimilar development and registration.

With deep expertise in biosimilars, regulatory affairs, and ANVISA compliance, Maven Regulatory Solutions is your trusted partner in navigating Brazil’s regulatory pathways and accelerating your journey to market.

Frequently Asked Questions 

1. What is RDC 875/2024?

A Brazilian regulation updating biosimilar approval pathways, introducing flexibility in clinical and non-clinical requirements.

2. Can international reference products be used in Brazil?

Yes, RDC 875/2024 allows the use of international reference biologics.

3. Are clinical trials always required for biosimilars?

Not always clinical requirements may be waived based on strong analytical comparability data.

4. What is ANVISA’s role in biosimilar approval?

ANVISA evaluates quality, safety, efficacy, and regulatory compliance of biosimilars in Brazil.