Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices

Abstract

Objectives: The aim of this study was to identify, compare and evaluate regulatory requirements for the biosimilar development and review processes in BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, Mexico) countries with mature regulatory systems of Australia, Canada, Singapore and Switzerland. It is hoped that this benchmark study provides an opportunity for BRICS-TM agencies to identify the key areas for improvement in their regulatory processes.Materials and Methods: A semi-quantitative questionnaire was developed covering the different criteria used in biosimilar development and registration process. Eleven regulatory agencies from BRICS-TM and ACSS (Australia, Canada, Switzerland and Singapore) countries were invited to take part in this study. Data processing and analysis was carried out using descriptive statistics for quantitative data and content analysis to generate themes for qualitative data.Results and Discussions: Nine of the 11 regulatory agencies recruited for the study completed the questionnaire. China and Singapore did not meet the deadline due to lack of resources. The organisational structure of BRICS-TM agencies revealed support from external assessors by most of these agencies in comparison with ACSS agencies. There was absence of reliance approach and participation in harmonisation activities across most BRICS-TM agencies. Despite alignment over biosimilarity, the mandate for in vivo non-clinical studies and additional local clinical studies in some of the BRICS-TM countries illustrates a lack of effective implementation of a step-wise approach. Adopting flexible regulatory standards in the sourcing of a RBP (Reference Biologic Product) by BRICS-TM similar to ACSS, will facilitate cost-effective development of biosimilar products.Conclusions: Comparative assessment of the biosimilar regulatory framework of BRICS-TM with ACSS agencies reveals the scope for enhancing efficiency of the regulatory approval process. To achieve this, BRICS-TM agencies should consider relying on reference agencies for alternative review mechanisms such as abridged or verification models, streamlined processes for providing scientific advice to developers and for waiving local clinical studies in-lieu of advanced scientific data.

Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice and Recommendations

“…The description of 43 articles is presented in Table 1 . 11 - 15 , 18 - 20 , 26 - 60 The research design included literature review (n = 3), 28 , 32 , 49 expert interview (n = 1), 48 empirical analysis (n = 2), 43 , 52 comparative analysis (n = 7), 12 , 15 , 35 , 42 , 47 , 58 , 59 retrospective analysis (n = 2), 19 , 41 questionnaire (n = 10), 14 , 20 , 26 , 27 , 37 - 40 , 55 , 56 description analysis (n = 6), 11 , 13 , 33 , 36 , 45 , 60 and mixed methods (n = 12). 18 , 29 - 31 , 34 , 44 , 46 , 50 , 51 , 53 , 54 , 57…”

“… 30 , 41 , 45 Additionally, the capacity required for effective regulatory decision-making process was also a topic of interest in 2 studies. 26 , 48 At the operation level, 7 studies were designed to identify the problems of the drug review process in the target area, 20 , 29 , 31 , 38 , 44 , 58 , 59 of which four studies focused on the new drug registration process. 25 , 43 , 57 , 58 The remaining 4 studies aimed to assess the regulatory functionalities related to pharmacovigilance, 28 , 37 vaccines 11 and clinical trials.…”

“…Previous literature mainly focused on a number of aspects of regulatory benchmarking including: the introduction of the practice of benchmarking NRA 11 ; the application of benchmarking NRAs for different purposes such as public health emergencies 12 , 13 and pharmacovigilance 14 , 15 ; various benchmarking tools or programmes such as the Global Benchmarking Tool (GBT) developed by the World Health Organization (WHO), 16 and Optimizing Efficiencies in Regulatory Agencies (OpERA) 17 ; and the country experiences of assessing and comparing regulatory capacities using benchmarking. 15 , 18 - 20 However, such literature is yet to be systematically analyzed and reviewed to depict an overall research landscape about how regulatory capacities can be approved through benchmarking NRAs. This is especially concerning when considering that, according to the WHO, 70% of its member states are not able to effectively and efficiently regulate medical products in their nations, especially in many low- and middle-income countries.…”

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

“…Biosimilar products are complex molecules produced using highly complex manufacturing processes. Due to the complexity of the biosimilar products, regulatory requirements for analytical comparability, non-clinical, and clinical studies vary with the geographies (25), particularly in emerging economies like BRICS-TM, as evident from the secondary research (8). Furthermore, with multiple prospective manufacturers on the horizon, the need arises for a streamlined regulatory guideline in emerging economies that ensure biosimilarity, comparability, and interchangeability with respect to safety and efficacy of the product (25).…”

“…Due to the complexity of the biosimilar products, regulatory requirements for analytical comparability, non-clinical, and clinical studies vary with the geographies (25), particularly in emerging economies like BRICS-TM, as evident from the secondary research (8). Furthermore, with multiple prospective manufacturers on the horizon, the need arises for a streamlined regulatory guideline in emerging economies that ensure biosimilarity, comparability, and interchangeability with respect to safety and efficacy of the product (25). Although substantial progress has been made in regulatory frameworks for chemical drugs, progress is less robust in developing countries, and implementing regulatory frameworks for biologic medicines, particularly biosimilar medicines (26).…”