Brazil: Anvisa updates its position on biosimilar interchangeability

Authors: Rob Rodrigues and Dara Offrede.

Brazil’s health regulatory agency has issued an important new technical position on the interchangeability of biosimilars, bringing the Brazilian approach closer to international regulatory practice and potentially supporting broader biosimilar adoption in clinical practice and public procurement.

Background

Biosimilars in Brazil are registered through a comparability exercise, historically governed by RDC No. 55/2010 and, more recently, complemented by RDC No. 875/2024. RDC No. 55/2010 established the minimum requirements for the registration of new biological products and biological products in Brazil, while RDC No. 875/2024 introduced complementary requirements for biosimilars registered through the comparability pathway, with the objective of ensuring quality, safety and efficacy.

According to Anvisa, the purpose of the comparability exercise is to demonstrate that the biosimilar candidate has a high degree of similarity to the biological comparator in terms of quality attributes, biological activity, safety and efficacy, and that any observed differences are not clinically relevant. Technical Note No. 60/2026 makes clear that the approval of a biosimilar continues to depend on this robust comparability assessment and that the new position does not amend the regulatory requirements applicable to biosimilar registration in Brazil.

The new position should also be viewed as part of a broader regulatory movement toward greater reliance on scientific comparability and international convergence in the assessment of biosimilars. RDC No. 875/2024 had already introduced additional flexibility into the Brazilian framework by allowing, under certain conditions, the waiver of non-clinical animal studies and clinical studies, provided that the applicant submits a technical-scientific justification grounded in guidelines issued by Anvisa or by equivalent foreign regulatory authorities. The rule also requires the applicant to demonstrate high comparability, functionality and characterization of the proposed biosimilar product.

What has changed?

The key development is Anvisa’s express recognition that the available scientific evidence supports the alternation between an Anvisa-approved biosimilar and its biological comparator, as well as between different biosimilars that share the same comparator product, provided that use remains consistent with the conditions approved in the marketing authorization.

In practical terms, Anvisa now states that biosimilars approved in Brazil may be used interchangeably with their comparator biological products, and also with other biosimilars of the same comparator, where appropriate safeguards are observed. These safeguards include patient guidance, traceability, pharmacovigilance, adequate clinical monitoring and compliance with the approved conditions of use.

The technical note defines interchangeability as the scientific-regulatory recognition that two medicines may be used in place of one another with the expectation of the same clinical effect. However, the document should be read as a technical and regulatory position on interchangeability, rather than as a standalone rule on automatic pharmacy substitution or a change to prescribing and dispensing frameworks.

Alignment with international practice

Anvisa’s updated position is expressly framed by reference to international experience. The agency notes that regulators and international bodies have increasingly accepted biosimilar interchangeability where products have been approved on the basis of robust comparability evidence.

This approach is consistent with the position of the European Medicines Agency and the Heads of Medicines Agencies, which have stated that biosimilars approved in the European Union may be considered interchangeable from a scientific perspective. The World Health Organization has also emphasized the role of biosimilars in expanding access to essential biological therapies, including through cost savings and broader availability.

Anvisa also refers to developments in other jurisdictions, including Canada, the United Kingdom, Finland and the United States. In the US, the FDA has proposed a less burdensome approach to interchangeability. Under its updated draft guidance, switching studies would generally not be needed to support a demonstration of interchangeability, reflecting FDA’s accumulated experience that, for biosimilars approved to date, the risk of diminished safety or efficacy following single or multiple switches is insignificant.

The regulatory rationale behind this trend is that biosimilar development is not intended to replicate the full development program of the reference biological product. Rather, it is based on a stepwise comparability exercise designed to rule out clinically meaningful differences between the biosimilar and the comparator product. As analytical and functional characterization techniques have become more sensitive, regulators have increasingly recognized that, for many biological products, residual uncertainty may be addressed without requiring duplicative clinical efficacy studies or dedicated switching studies in all cases.

A broader trend in Brazilian biosimilar regulation

Technical Note No. 60/2026 fits within a broader evolution of the Brazilian regulatory framework for biosimilars. Recent developments suggest that Anvisa is moving toward a model that places greater weight on robust analytical comparability, accumulated scientific knowledge and international regulatory experience.

This trend was already visible in RDC No. 875/2024, which allowed Anvisa to waive certain non-clinical and clinical studies for biosimilar registration where the applicant provides an adequate technical-scientific justification based on Anvisa guidelines or on guidelines issued by equivalent foreign regulatory authorities. Technical Note No. 60/2026 takes this evolution further into the post-approval setting: once biosimilarity has been established through a robust comparability exercise, Anvisa now recognizes that alternation between the biosimilar and the comparator, or between biosimilars sharing the same comparator, may be supported from a scientific and regulatory perspective.

This movement is also consistent with the public health role attributed to biosimilars internationally. As noted in the technical note, biosimilars have become important instruments for expanding access to biological therapies, including by contributing to broader availability and potential cost savings for healthcare systems. In Brazil, this may be particularly relevant in the context of public procurement, institutional treatment protocols, payer negotiations and hospital formulary decisions.

At the same time, the note is not simply a statement in favor of broader access or cost reduction. Its emphasis is on qualified confidence in biosimilars: confidence built on the prior comparability assessment, accumulated scientific evidence and operational safeguards such as patient communication, traceability, pharmacovigilance, documentation of changes and adequate clinical monitoring.

Taken together, RDC No. 875/2024 and Technical Note No. 60/2026 indicate a gradual shift from a more conservative approach to a model of qualified regulatory confidence in biosimilars. Broader access to biological therapies is a relevant and expected outcome of this evolution, but it depends on the continued observance of the safeguards identified by Anvisa.

Required safeguards: communication, traceability and pharmacovigilance

The technical note places significant emphasis on the operational safeguards that should accompany alternation between biological products. In particular, Anvisa identifies the following measures as essential when changing between a comparator biological product and a biosimilar, or between biosimilars:

clear and transparent communication with patients;

education and training for healthcare professionals, managers and decision-makers;

proper documentation of the switch or alternation between products;

traceability, including unequivocal identification of the product and batch; and

clarity in prescribing and product information made available to healthcare professionals.

The agency also highlights the importance of managing patient expectations, including awareness of the so-called “nocebo” effect, where negative expectations regarding a change in treatment may contribute to perceived or reported adverse outcomes unrelated to the pharmacological effect of the medicine.

From a pharmacovigilance perspective, Anvisa cautions that frequent or unplanned alternations may create practical challenges for monitoring, traceability and risk management. As a result, while the agency considers properly managed alternation to be safe and effective, the process should be planned, documented and supported by adequate clinical follow-up.

Regulatory transparency

The technical note also points to Anvisa’s use of the Public Assessment Report for Medicines, known in Brazil as the PPAM, as an instrument of regulatory transparency. Since 2015, Anvisa has published approval reports setting out the technical and scientific bases for certain approval and rejection decisions. For biological medicines, including biosimilars, these reports may provide useful information regarding the data assessed by the agency on quality, safety and efficacy.

This transparency may become increasingly relevant for companies, healthcare institutions and payers assessing the use of biosimilars in switching policies, procurement procedures and treatment protocols.

Practical implications for life sciences companies

The new Anvisa position may have significant commercial and strategic consequences for both originator companies and biosimilar manufacturers.

For biosimilar manufacturers, the technical note provides stronger regulatory support for market access strategies based on switching, alternation and inclusion in treatment protocols or procurement processes. It may also help reduce uncertainty among prescribers, payers and hospital systems that have historically been cautious about changing biological treatments.

For originator companies, the update may increase competitive pressure in therapeutic areas where biosimilars are available or expected to enter the market. The practical impact may be particularly relevant in public tenders, private payer negotiations and hospital formulary decisions.

For all stakeholders, the message is that interchangeability should be implemented responsibly. Companies should review medical information materials, pharmacovigilance procedures, traceability systems, market access communications and field-force training to ensure that any discussion of biosimilar interchangeability remains aligned with Anvisa’s position and the approved conditions of use.

Patent and litigation considerations

Although Technical Note No. 60/2026 does not alter patent rights, regulatory data protection issues or the substantive rules governing market entry, it may affect the commercial context in which biologics disputes arise.

In particular, stronger regulatory acceptance of biosimilar interchangeability may influence launch planning, damages assessments, public interest arguments in preliminary injunction disputes, and the market impact of biosimilar entry following loss of exclusivity. Originator and biosimilar companies should therefore consider the update not only as a regulatory development, but also as part of the broader competitive landscape for biological medicines in Brazil.

This broader reliance on comparability and accumulated scientific knowledge may also keep regulatory data protection and data reliance issues on the radar, although Technical Note No. 60/2026 itself does not address or modify those matters.

Conclusion

Anvisa’s Technical Note No. 60/2026 represents an important clarification of the Brazilian regulatory position on biosimilar interchangeability. While it does not change the legal requirements for biosimilar approval, it expressly recognizes that approved biosimilars may be used in alternation with their comparator biological products and with other biosimilars sharing the same comparator, provided that approved conditions of use and appropriate safeguards — including patient communication, traceability, pharmacovigilance and clinical monitoring — are observed.

The note also reflects a broader regulatory trend toward greater reliance on robust comparability, accumulated scientific evidence and international regulatory experience, already visible in RDC No. 875/2024. This topic is expected to remain on Anvisa’s regulatory agenda for 2026–2027, which includes the update of technical and regulatory requirements for the registration of biological products. Although the specific developments are still to be seen, further discussions may help consolidate greater regulatory clarity, international convergence and reliance on robust comparability standards.

For the Brazilian life sciences market, this is a meaningful step toward greater confidence in biosimilars, closer alignment with international regulatory practice, and a clearer scientific and regulatory basis for their broader use in clinical practice, healthcare policy and procurement.