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

In June 2024, a significant regulatory update for biosimilars in Brazil was introduced with the publication of Resolution RDC No. 875, which modified the existing framework outlined in RDC 55/2010. This new regulation aims to simplify the registration and approval process for follow-on biological products, introducing key changes that make it easier for companies to bring biosimilars to the Brazilian market while maintaining high standards of safety and efficacy.

Key Changes with RDC 875/2024

The resolution is part of Brazil’s ongoing efforts to encourage the development of biosimilars in the country, making it more accessible for companies to register these products. Key provisions of RDC 875/2024 include:

1. Comparability Pathway for Biosimilars
The regulation continues to support the comparability pathway for biosimilars, allowing these products to be registered based on demonstrating similarity to a reference biological product. This pathway is more streamlined and cost-effective compared to developing an entirely new biological product from scratch. This approach ensures that the safety and efficacy of the biosimilar are comparable to the reference, providing a robust and scientifically sound regulatory pathway.

2. International Reference Drug
A significant innovation introduced by RDC 875/2024 is the allowance for using an international reference drug in cases where the original biological product is not available on the Brazilian market. This change provides companies with greater flexibility, particularly for products that have not been previously registered in Brazil, making it easier to introduce biosimilars that align with global standards.

3. Non-Clinical and Comparative Clinical Studies
RDC 875/2024 allows for the dispensation of non-clinical and comparative clinical studies in certain cases, if characterization data of the molecule is sufficient. This adjustment reduces the regulatory burden on companies, accelerating the approval process while ensuring that necessary safety data remains in place. For example, a company may be able to bypass some clinical trial requirements if robust in vitro or preclinical data support the comparability of the biosimilar to the reference product.

4. Engagement with the Regulated Sector
The update was shaped through extensive consultations with the regulated sector, starting with Call 15/2022 and continuing through Sector Dialogues and Public Consultations. This ensures that the final regulation aligns with industry needs while maintaining rigorous safety and quality standards.

Maven’s Expertise in Navigating the Brazilian Biosimilars Market

At Maven, we understand the intricacies of launching products in Brazil and are here to provide comprehensive support through every step of the regulatory process, including compliance with the newly revised RDC 875/2024. Our expert team specializes in helping clients understand and navigate regulatory requirements, ensuring that all technical documentation and submission processes meet the latest standards set by ANVISA.

Here’s how Maven supports your biosimilars journey:

1. Regulatory Strategy Development
We assist in creating tailored regulatory strategies, ensuring your biosimilar meets all requirements for approval under RDC 875/2024, from comparability pathways to clinical data requirements.

2. Dossier Preparation
Our team can prepare and compile the required documentation for registration, including data on comparability studies, manufacturing processes, and any necessary clinical or non-clinical studies.

3. Regulatory Submissions
Maven guides you through the submission process, ensuring that all applications to ANVISA are accurate, complete, and aligned with Brazilian regulations.

4. Market Access
We provide insights into market access strategies, helping you navigate the Brazilian regulatory landscape and ensuring a smooth path to market entry.

5. Ongoing Compliance Support
As regulations evolve, we offer continuous updates and guidance, helping you maintain compliance with Brazilian standards and ensuring your biosimilar’s success in the market.

Conclusion

RDC 875/2024 represents a pivotal change in the regulatory framework for biosimilars in Brazil, offering more flexibility and opportunities for companies looking to introduce follow-on biological products to the market. With Maven's expertise in regulatory affairs and biosimilar development, we provide end-to-end support to ensure that your product meets all the necessary requirements for successful registration and market entry.

Whether you're navigating comparability data, preparing for clinical trials, or submitting to ANVISA, Maven is your trusted partner in bringing biosimilars to Brazil. Reach out to us today to learn how we can help you navigate this evolving regulatory landscape and successfully launch your product in Brazil.