Latin America

Limited healthcare resources across many Latin American countries mean that important biologics for conditions such as cancer and rheumatoid arthritis (RA) are being underutilized, due largely to their cost and a lack of reimbursement from state health insurance programs. These factors contribute to suboptimal adoption of clinical best practice recommendations and inequality of care across the region. Payers are increasingly looking to biosimilars to help curb healthcare expenditure and broaden patient access. Legislation to ensure the quality, safety, and efficacy of biosimilars, and enforce rigorous regulatory and testing standards, already exists in the region, but varies from country to country. Currently, several biosimilars are being developed and tested in Latin America, under such legislation, for conditions ranging from RA to breast cancer and non-small cell lung cancer. 

Current access to originator biologics in Latin America   +

In Latin American countries, where healthcare resources are often limited, the high cost of biologics is a major barrier in clinical practice. Important biologics for conditions such as cancer and RA are underutilized, due largely to a lack of reimbursement from state health insurance and the resulting ‘out-of-pocket’ expenses that are frequently unaffordable for patients. Consequently, adherence to clinical best practice is often not feasible and quality of care varies widely.

  • Trastuzumab, the first of the HER2 (human epidermal growth factor receptor 2)-directed therapies, has dramatically improved outcomes for patients with early1 or metastatic breast cancer.2 However, clinical oncologists surveyed in Mexico and Brazil frequently cite cost as a barrier to prescribing trastuzumab.3 In Peru, more than half of the population depend on public healthcare, which does not cover the cost of breast cancer treatment.4
  • Rituximab, an important advance in lymphoma treatment, is effective in the treatment of a wide variety of hematologic malignancies.5 However, many physicians (surveyed in Mexico and Brazil) are either unable to prescribe rituximab or have to deviate from treatment guidelines, largely because of cost.6
  • Anti-angiogenic biologics for use in metastatic colorectal cancer are not covered by public health insurance in a number of Latin American countries, such as Brazil and Peru, meaning that many eligible patients who could benefit from these treatments are denied them.7

  • Biologics have greatly improved RA care, but access to these therapies is restricted in some Latin America countries because of limited reimbursement and the resulting high out-of-pocket costs.8,9 In Mexico, the high cost of RA biologics means that they are available to only a few privately insured patients. Even those who are covered may still need to find a way to pay upfront, because some insurance companies do not pre-pay for the treatment.10
  • In Argentina, patient access to insulin analogues is limited. They are not covered in the public healthcare sector and access within the social security and private healthcare sectors is subject to an audit system, which requires the physician to demonstrate in writing that insulin analogue treatment is essential to their patient.11  

Learn more about Biosimilars by Disease >>

Regulatory guidelines in Latin America   +

Legislation to ensure the quality, safety, and efficacy of biosimilars, and maintain rigorous regulatory and testing standards, already exists in several Latin American countries, based largely on European Medicines Agency (EMA) and World Health Organization (WHO) guidance (see table).13,14 Brazil, Argentina, and Mexico are the current regulatory front-runners. The Latin American biosimilar regulatory landscape is diverse but appears to be collectively gravitating towards an increased quality standard.12

However, it is important to note that some earlier versions of non-originator biologics – known as ‘copy biologics’ – were licensed in Latin America before the introduction of formal regulatory guidance requiring rigorous comparability testing (equivalent or close to the international standards). Copy biologics and biosimilars should be differentiated from a regulatory perspective, but unfortunately local reports and statistics do not always reflect this differentiation.  

The regulatory situation in individual Latin American countries is as follows:

  • Brazil is unusual in having two regulatory pathways – the ‘comparative’ pathway and the ‘individual development’ pathway, both introduced by the National Health Surveillance Agency (ANVISA) in 2010. The comparative pathway, which is based on the WHO biosimilarity guidelines, is in alignment with international standards for biosimilar approval, and products licensed via this route are considered to be biosimilars.15  ANVISA approved its first biosimilar (Remsima, an infliximab biosimilar) via this pathway in 2015.16
  • The individual development pathway is not based on comparisons with originators and requires a full dossier of data.
  • Argentina introduced a formal regulatory pathway in 2011 and has been instrumental in establishing the need for rigorous approval standards in Latin America.17,18  
  • Mexico established its biosimilar regulatory pathway in 2012, but this did not officially take effect until early 2015.19,20 The Mexican regulatory body COFEPRIS now requires manufacturers of biologic copy products licensed before the new regulations were enforced to reapply for approval of their products as biosimilars, with all the necessary evidence.21
  • Chile has yet to release biosimilar guidance, but a draft issued in 2011 suggests Chilean regulators will draw upon the EMA and WHO guidelines.12,13,22
  • Colombia issued draft guidelines in 2013, which have yet to be finalized. In the interim, some stakeholders have expressed concern that, although the draft guidelines declare that the required data must show the quality, efficacy, and safety of a biosimilar, there are currently no specifications in the draft as to how these properties should be demonstrated by the applicant.23

Biosimilars regulation across Latin America

Country Regulatory agency Biosimilar regulation Approved biosimilars*
(February 2015)
Administration of Drugs, Foods and Medical Devices of Argentina
Final guidance issued December 2011.17
Go now!
Yes (also copy biologics)
National Health Surveillance Agency of Brazil
Final guidance issued December 2010.24
Go now!
Yes (also copy biologics)
National Drug Agency
No. Published draft proposals.25
Go now!
None – copy biologics only
National Food and Drug Surveillance Institute
No. Published draft proposals.25
Go now!
None – copy biologics only
Federal Commission for the Protection against Sanitary Risks
Final guidance issued April 2012.20 Go now!
Biosimilars in Mexico are called ‘biocomparables’
None – copy biologics only
*Products approved before the date of the national regulatory guidance may not have undergone full comparability/biosimilarity testing and are considered ‘copy biologics’ rather than biosimilars

Learn more about Regulatory Requirements >> 
Learn more about Biosimilars >>

Biosimilar approvals in Latin America   +

Argentina and Brazil have both started to approve biosimilars in line with formal regulatory guidance. The financial impact is yet to be assessed; however, copy biologics (see ‘Are all copies of biologics considered biosimilars?’ in the Regulatory Requirements section) are in clinical use in several Latin American countries, e.g. over 20 products in Mexico (known locally as ‘biolimbos’). Importantly, in March 2015, the Mexican regulatory body COFEPRIS announced that all non-originator biological products registered before the formal approval framework was established would need to re-apply for licensing as biosimilars (or ‘biocomparables’ as they are known locally) in line with the new requirements.19   

The future of biosimilars in Latin America   +

Biologics in Latin America account for a large percentage of pharmaceutical spending but only a small number of prescriptions.12,15 Payers are increasingly looking to biosimilars to help curb healthcare expenditure and broaden patient access.12,15 In many Latin American countries, biosimilars for conditions such as RA, breast cancer, and non-small cell lung cancer are currently being developed and may soon be ready to submit applications.26

"In Argentina, payers foresee that the launch of biosimilars will reduce costs, expand formulary inclusion and improve patient access." 27
Andreia Ribeiro, PhD, Decision Resources Director 

Foreign pharmaceutical companies with established clinical development expertise are teaming up with local companies offering regional expertise.26 In addition, in several Latin American countries including Brazil, Argentina, and Mexico, ‘local champions’ in biosimilar development are emerging.12

References   +

  1. The ASCO Post, 1 March 2013. Final 'joint analysis' confirms life-saving benefit of trastuzumab in patients with her2-positive early breast cancer.,-2013/final-joint-analysis-confirms-life-saving-benefit-of-trastuzumab-in-patients-with-her2-positive-early-breast-cancer.aspx. Accessed 10 December 2015.
  2. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med (2001) 344:783–792.
  3. Lammers P, Criscitiello C, Curigliano G et al. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. Pharmaceuticals (2014) 7:943–953.
  4. Justo N, Wilking N, Jönsson B et al. A review of breast cancer care and outcomes in Latin America. Oncologist (2013) 18:248–256.
  5. OncLive, 15 March 2011. The clinical and economic value of rituximab for the treatment of hematologic malignancies. Accessed 18 February 2015.
  6. Baer II WH, Maini A & Jacobs I. Barriers to the access and use of rituximab in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician survey. Pharmaceuticals (2014) 7:530–544.
  7. The Angiogenesis Foundation. Improving outcomes in the treatment and management of metastatic colorectal cancer in Latin America. A report based on a Latin American expert summit for metastatic colorectal cancer convened in Buenos Aires, Argentina, January 2014. Accessed 18 February 2015.
  8. Burgos-Vargas R, Catoggio LJ, Galarza-Maldonado C et al. Current therapies in rheumatoid arthritis: A Latin American perspective. Reumatol Clin (2013) 9:106–112.
  9. Mysler E & Scheinberg M. Biosimilars in rheumatology: a view from Latin America. Clin Rheumatol (2012) 31:1279–1280.
  10. Comparator A survey of barriers to treatment access in rheumatoid arthritis. Country annex report: Mexico. March 2010. Accessed 18 February 2015.
  11. Caporale JE, Elgart JF & Gagliardino JJ. Diabetes in Argentina: cost and management of diabetes and its complications and challenges for health policy. Global Health (2013) 9:54.
  12. PMLiVE, 10 April 2013. Unfolding the biosimilar landscape in Latin America. Accessed 18 February 2015.
  13. GaBI Online, 17 April 2013. Biosimilarity in Latin America. Accessed 19 February 2015.
  14. Castañeda-Hernández G, Szekanecz Z, Mysler E et al. Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: innovators, biosimilars, and intended copies. Joint Bone Spine (2014) 81:417–477.
  15. Azevedo VF, Sandorff E, Siemak B & Halbert RJ. Potential regulatory and commercial environment for biosimilars in Latin America. Value Health Reg Issues (2012) 1:228–234.
  16. PR Newswire, 2 June 2015. ANVISA approves first infliximab biosimilar in Brazil. Accessed 2 November 2015.
  17. Regulatory Affairs in Latin America. Registration of biological drug products in Argentina. Accessed 16 March 2015.
  18. BioPharma Reporter, 8 October 2014. Uptake of biosimilars across Latin America surges as regulations vary. Accessed 2 November 2015.
  19. One Quality Standard. New Mexican biosimilar rules on biosimilars take effect in Mexico. Accessed 12 March 2015.
  20. Generics and Biosimilars Initiative (GaBI). Mexican biocomparables guidelines come into force. Accessed 19 February 2015.
  21. GaBI Online, 13 March 2015. Mexico issues rules on biolimbos. Accessed 2 November 2015.
  22. BioPharma, 8 October 2014. Uptake of biosimilars across Latin America surges as regulations vary. Accessed 19 February 2015.
  23. Institute for Patient Access (IfPA), 11 August 2015. GAfPA encourages standards-based guidelines for Colombia’s biosimilars. Accessed 2 November 2015.
  24. GaBI Online, 31 October 2013. Brazilian guidelines for follow-on biological products. Accessed 10 December 2015.
  25. Álvarez AA, Mysler E, Ruiz de Castilla EM et al. Recommendations for the regulation of biosimilars and their implementation in Latin America. GaBI Journal (2014) 3:143–148.
  26. PMLiVE. Current development and marketing of biosimilar monoclonal antibodies in Latin America. Accessed 19 February 2015.
  27. Decision Resources, 28 October 2013. Despite formulary coverage of several biologic agents for rheumatoid arthritis in Argentina and Mexico, low biologic treatment rates characterize these markets. Accessed 18 February 2015.