On 25 September 2024, the Brazilian Society of Rheumatology (SBR, Sociedade Brasileira de Reumatologia) shared its position and consensus on the interchangeability between reference products and biosimilars, a topic of great importance for clinical practice, especially in light of recent regulatory developments by Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária) and other international authorities.
The use of biological medicines has revolutionized the treatment of various conditions, including rheumatic diseases. However, due to the complex production processes involved, the introduction of biosimilars—highly similar versions of reference products—has raised concerns about their safety and efficacy.
The SBR position statement aims to clarify the fundamental principles that ensure the safety and continuityof treatment with biosimilars, while emphasizing the importance of pharmacovigilance and clear communication between healthcare professionals and patients.
Regulatory Framework for Biosimilars in Brazil
The term ‘biosimilars’ refers to products that have been approved in Brazil through a comparability pathway, as outlined by Resolution of the Collegiate Board of Directors (DRC) No. 55/2010 [1], and most recently updated by DRC No. 875/2024 [2]. This approval process aligns with international standards set by the World Health Organization and other regulatory bodies such as the European Medicines Agency, Health Canada, and the US Food and Drug Administration.
The goal of this comparability approach is to ensure that a biosimilar demonstrates no significant differences in quality, safety, or efficacy compared to the reference product, typically through equivalence or non-inferiority testing.
The Role of Biosimilars in Brazil's Healthcare System
In Brazil, biosimilars play a crucial role in improving access to essential treatments, reducing costs, and strengthening the health system, fostering competition and innovation in the pharmaceutical sector [3].
Brazil was the first Latin American country to regulate biosimilars, doing so in 2010 [4]. The first biosimilar approved by ANVISA was Remsima, an infliximab biosimilar, in April 2015 [5]. Since then, more than 52 biosimilars have been launched in Brazil [6].
The Biotechnology Committee of SBR reaffirms its support for the introduction of biosimilars in Brazil, in alignment with ANVISA's approval process, and stresses the importance of upholding the following key principles:
1. The prescribing doctor does not need to individually authorise switches to or between biosimilars but must be aware of the medicine being dispensed.
2. If a prescribing doctor disagrees with a switch or recommends reverting to the originator, they should have a clear communication channel for such concerns. However, any disagreement must be backed by a clear scientific rationale and should only occur in exceptional cases.
3. Reverse switches—returning from a biosimilar to the originator—should only occur in exceptional cases, such as when a patient experiences an adverse event or loss of efficacy, as determined by their doctor, excluding the nocebo effect.
4. Multiple switches between the originator and biosimilar, or between different biosimilars, should be avoided within a period of less than one year.
5. Medicine shortages, including during switches, should be avoided, as irregular supplies can lead to clinical instability and compromise treatment effectiveness.
6. The ideal candidate for switching immunobiological drugs is clinically stable patient with effective, well-tolerated therapy, demonstrating low disease activity or inactive disease.
Conclusion: Expanding Access Safely
Interchangeability between reference products and biosimilars, supported by robust scientific evidence, is essential for expanding access to critical medicines and ensuring the sustainability of the health system. The SBR reaffirms its support for the incorporation of biosimilars, while emphasizing principles that safeguard patient safety, therapeutic efficacy, and the continuity of treatment.
Healthcare professionals must be proactive in pharmacovigilance and patient education, ensuring a safe and informed transition between biological treatments.
Related articles
American College of Rheumatology position statement on biosimilars updated
PANLAR issues consensus statement on biosimilars
References
1. GaBI Online - Generics and Biosimilars Initiative. Brazilian guidelines for follow-on biological products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/guidelines/Brazilian-guidelines-for-follow-on-biological-products
2. GaBI Online - Generics and Biosimilars Initiative. New regulations in Brazil for the registration of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/guidelines/new-regulations-in-brazil-for-the-registration-of-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Ten best-selling biosimilars in Brazil in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/biosimilars/general/ten-best-selling-biosimilars-in-brazil-in-2023
4. GaBI Online - Generics and Biosimilars Initiative. Brazilian market of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/reports/brazilian-market-of-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 13]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-brazil
6. Cestari de Oliveira SH. Follow-on biologicals/biosimilars approved in Brazil: May 2024 update. Generics Biosimilars Initiative Journal. (GaBI Journal). 2023;12(2):67-72. doi:10.5639/gabij.2023.1202.012
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