Teran et al., experts in biological cancer therapies and health economics, first identified numerous regulatory challenges for biosimilars which included heterogeneous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars, imprecise use of interchangeability, and substitution and insufficient traceability and pharmacovigilance [3].

Recommendations were then developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to cancer therapies. Those recommendations are the following [3]:

A. Developing homogeneous and comprehensive regulations
Regulations in Latin America could be improved to make them more homogenous and comprehensive than those currently in place.

Regulatory pathways for biosimilars should be aligned to international standards provided by the World Health Organization (WHO) or the US Food and Administration (FDA) or the European Medicines Agency (EMA) [4].

B. Increasing traceability and pharmacovigilance
1. Government, regulatory authorities, medical societies, academia and healthcare providers - to implement strategies to ensure traceability through the manufacturing, distribution and prescription processes of biosimilars by means of a well-documented identification system
2. Government and regulatory entities - to coordinate traceability and pharmacovigilance efforts
3. Professional personnel – to be adequately trained to report, analyse and monitor adverse effects of biosimilars
4. Monitoring of outcomes with adequate indicators such as access to therapies, health outcomes and cost savings should be implemented to measure the effects of biosimilar use.

C. Increasing market opportunities and improving procurement strategies
A welcoming procurement environment for biosimilars by fostering access strategies and clearly including biosimilars in local clinical practice guidelines should be created.

The adoption of more cost-effective drugs could be favoured by increasing participation of numerous stakeholders in the benefits obtained from biosimilar costs reductions. It is also possible to develop co-payment and reimbursement policies to involve patients in the decision-making process regarding the use of either originators or biosimilars.

D. Increasing educational opportunities
In order to increase the trust in biosimilars and dissipate prejudgements on the efficacy and the safety of biosimilars, medical societies, academia, governments, regulatory authorities, patient advocacy groups and non-governmental organizations should offer educational content to medical community and patients.

To overcome these issues on cancer treatments, all aspects of biosimilar use should be addressed in national and regional guidelines on colorectal cancer and breast cancer, including interchangeability. Furthermore, existing patient groups can benefit from these educational opportunities to increase their knowledge on disease and treatment.

The challenges are to educate and communicate in a broad and sustained manner about the evidence of effectiveness and safety of biosimilars [5].

Biosimilars are a safe, effective and equivalent alternative to originator biologicals, which contribute to the sustainability and financing of healthcare systems and favour access to biological therapies [3]. Thus, biosimilars are the option for more and more patients to have access to biotherapies in the fight, among others, against oncological diseases [5].

Related articles
Biosimilar regulations perspective in Latin America to improve cancer treatment access

Recommendations for the regulation of biosimilars and their implementation in Latin America

References
1. GaBI Online - Generics and Biosimilars Initiative. Regulatory landscape for biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. Available from: www.gabionline.net/biosimilars/research/regulatory-landscape-for-biosimilars-in-latin-america
2. GaBI Online - Generics and Biosimilars Initiative. Access to biosimilars for cancer treatments in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. Available from: www.gabionline.net/biosimilars/research/access-to-biosimilars-for-cancer-treatments-in-latin-america
3. Teran E, Gomez H, Hannois D, et al. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. Lancet Oncol. 2022 Jul;23(7):e348-e358. doi: 10.1016/S1470-2045(22)00121-8. PMID: 35772466.
4. GaBI Online - Generics and Biosimilars Initiative. Recommendations for improving biosimilar regulations in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. 
5. GaBI Online - Generics and Biosimilars Initiative. Benefits of innovative biologicals and biosimilars for patients and health systems [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. Available from: www.gabionline.net/reports/benefits-of-innovative-biologicals-and-biosimilars-for-patients-and-health-systems

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