Table 4.
Breakdown of challenges in biosimilar development and approval process in BRICS-TM according to functions of the study participants
| Identified challenges | Country | Prevalence of responses (%) | Level of concordance of the responses |
|---|---|---|---|
| Regulatory affairs (RA) | |||
| Evolving guidelines with tedious review process | Brazil | 33.3 | Low concern |
| Russia | 50 | High concern | |
| India | 60 | High concern | |
| China | NA | NA | |
| South Africa | 100 | High concern | |
| Turkey | 0 | No concern | |
| Mexico | 100 | High concern | |
| Confirmatory clinical safety and efficacy studies | Brazil | 66.67 | High concern |
| Russia | 100 | High concern | |
| India | 80 | High concern | |
| China | NA | NA | |
| South Africa | 100 | High concern | |
| Turkey | 100 | High concern | |
| Mexico | 0 | No concern | |
| Reliance and absence of abridged review pathway | Brazil | 33.33 | Low concern |
| Russia | 50 | High concern | |
| India | 100 | High concern | |
| China | NA | NA | |
| South Africa | 0 | No concern | |
| Turkey | 0 | No concern | |
| Mexico | 0 | No concern | |
| Research & development (R&D) | |||
| Mandatory non-clinical studies (in vitro and in vivo studies) | Brazil | NA | NA |
| Russia | NA | NA | |
| India | 100 | High concern | |
| China | NA | NA | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | 100 | High concern | |
| Lack of specific and binding scientific advice | Brazil | NA | NA |
| Russia | NA | NA | |
| India | 100 | High concern | |
| China | NA | NA | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | 100 | High concern | |
| Lack of harmonized guideline for biosimilar development across BRICS-TM | Brazil | NA | NA |
| Russia | NA | NA | |
| India | 100 | High concern | |
| China | NA | NA | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | 100 | High concern | |
| Business development (BD) | |||
| Late and unsure return on investment considering high cost involved | Brazil | 100 | High concern |
| Russia | NA | NA | |
| India | 100 | High concern | |
| China | 100 | High concern | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | NA | NA | |
| Pressure on pricing from Health Authorities/Insurers/Procurement Authority | Brazil | 100 | High concern |
| Russia | NA | NA | |
| India | 80 | High concern | |
| China | 0 | No concern | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | NA | NA | |
| Sourcing of multiple RBP lots | Brazil | 100 | High concern |
| Russia | NA | NA | |
| India | 60 | High concern | |
| China | 100 | High concern | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | NA | NA | |
| Technical operations | |||
| In-house expertise and infrastructure | Brazil | NA | NA |
| Russia | 50 | High concern | |
| India | 100 | High concern | |
| China | NA | NA | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | NA | NA | |
| Submission and commercialization of three batches of validation | Brazil | NA | NA |
| Russia | 50 | High concern | |
| India | 75 | High concern | |
| China | NA | NA | |
| South Africa | NA | NA | |
| Turkey | NA | NA | |
| Mexico | 50 | High concern | |
If % outcome of respondents is ≥ 50 = high concern, < 50 = low concern, 0 = no concern
BRICS-TM Brazil, Russia, India, China, South Africa, Turkey, Mexico, NA Not Applicable, RBP Reference Biological Product