Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. However, Latin America still faces several significant challenges. The obstacles and advancements experienced in recent years are detailed below.
Challenges and progress in the registration of biosimilars in Latin America
Biosimilars/General
|
Posted 25/06/2024
0
Post your comment
![Application V15a16 Application V15a16](/var/gabi/storage/images/media/images/application-v15a16/25577-1-eng-GB/Application-V15a16_large.jpg)
Challenges
– Regulatory frameworks (inconsistent regulations): the lack of specific and harmonized regulations for the registration of biosimilars in some countries complicates the approval process. Establishing clear and consistent standards is crucial to ensure the safety and effectiveness of these medicines.
– Investment in R&D (funding deficiencies): limited investment in research and a scarcity of regional or global developments hinder progress.
– Training and expertise (skill gaps): the lack of experts and technical personnel in biosimilars prevents overcoming regulatory hurdles and promoting the development of innovative products.
– Technical complexity (advanced analysis requirements): biosimilars are complex molecules, and their characterization requires advanced analytical techniques. This may pose certain challenges in terms of demonstrating similarity to the reference product and ensuring its quality, safety, and efficacy.
– Perception and trust (variable confidence): healthcare professionals and patients often have varying perceptions regarding the equivalence of biosimilars and reference products. This lack of trust can impede the adoption and usage of biosimilars, even when available in the market.
– Access and costs (economic barriers): although biosimilars are marketed as cheaper alternatives to reference products, costs can still be significant.
Progress and Developments
– Regulatory harmonization (collaborative efforts): significant efforts have been made toward harmonizing biosimilar regulations in Latin America. Collaboration between Latin American regulatory agencies and the exchange of best practices are contributing to this progress.
– Education and awareness (awareness campaigns): initiatives aimed at educating healthcare professionals and patients about biosimilars are ongoing. These campaigns emphasize the safety, efficacy, and equivalence of biosimilars with reference products, helping to build confidence in these medications and encourage their appropriate use.
Noteworthy Initiatives
1. Brazil’s Strategic Plan
ANVISA’s 2024-2027 Agenda
Brazil's National Health Surveillance Agency (ANVISA) has developed a strategic plan for 2024-2027, aiming for the World Health Organization (WHO) recognition. Priorities include adopting Identification of Medicinal Products (IDMP) standards and the modernizing data platforms to enhance regulatory processes.
2. Mexico's Regulatory Improvements
COFEPRIS's 2024 Agenda
Mexico's Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has outlined its 2024 agenda, focusing on improving regulatory certainty, promoting digitalization, enhancing manufacturing capabilities to meet international standards, and launching a biosimilars unit and pharmaceutical development committee [1].
Pablo Quiroga, Executive Director of Health Promotion at COFEPRIS, highlights the interest in biosimilars in Mexico due to regulatory advances and strategic opportunities. However, he faces challenges in regulation and awareness that must be addressed to ensure market success. The risk of not addressing these challenges could affect production and competition in the biosimilar sector.
Conclusion
While significant challenges remain, Latin America is making noteworthy progress in the biosimilar sector. Efforts to harmonize regulations, educate stakeholders, and modernize regulatory frameworks are pivotal steps forward. With continued investment in R&D, training, and awareness, the region can overcome barriers and fully realize the benefits of biosimilar medicines.
The regulatory situation of biosimilars in Latin America varies widely between different countries, despite the fact that the region is moving towards the consolidation of defined and standardized regulatory pathways for these products [2].
Related articles
COFEPRIS promotes regulatory cooperation in the Americas
The effects of regulation on innovation in Mexican pharmaceutical industry
LATIN AMERICAN FORUM View the latest headline article: Descifrando las negociaciones sobre los precios de los medicamentos de la US IRA y Medicare Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO Ver el último artículo de cabecera: Descifrando las negociaciones sobre los precios de los medicamentos de la US IRA y Medicare !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
References
1. GaBI Online - Generics and Biosimilars Initiative. Strategic plans of ANVISA and COFEPRIS to advance health regulation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 25]. Available from: www.gabionline.net/policies-legislation/strategic-plans-of-anvisa-and-cofepris-to-advance-health-regulation
2. GaBI Online - Generics and Biosimilars Initiative. Regulatory landscape for biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jun 25]. Available from: www.gabionline.net/biosimilars/research/regulatory-landscape-for-biosimilars-in-latin-america
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
Research
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Biosimilars in inflammatory bowel disease: are we ready for multiple switches
Boehringer Ingelheim to expand access to adalimumab biosimilar
![Discount Save money V15c13 Discount Save money V15c13](/var/gabi/storage/images/media/images/discount-save-money-v15c13/26282-1-eng-GB/Discount-Save-money-V15c13_large.jpg)
Biosimilars/General Posted 03/07/2024
Canada's path to biosimilar adoption and healthcare accessibility: insights from British Columbia
![19646665_l 19646665_l](/var/gabi/storage/images/media/images/19646665_l2/55733-1-eng-GB/19646665_l_large.jpg)
Biosimilars/General Posted 19/06/2024
The best selling biotechnology drugs of 2008: the next biosimilars targets
![picture09 picture09](/var/gabi/storage/images/media/images/picture09/2207-2-eng-GB/picture09_large.jpg)
Post your comment