Table 2.
Summary of Critical Considerations During the Evaluation of Biosimilars Based on Subsequent Steps of Formulary Evaluation.
| Key considerations | Specific details |
|---|---|
| Initial review | What are the considerations for systematic approach for the evaluation of a biosimilar? |
| Available biosimilar products | • What are the current available biosimilars on the market? |
| • Is the product classified as biosimilar, non-innovator, or biobetter? | |
| • Which regulatory body approved the product? | |
| Substitution, interchangeability, switching | • Will the reference product stay on the formulary? |
| • Will there be a complete switch to the biosimilar? | |
| • Are there any potential risks in switching to the biosimilar? | |
| Extrapolation of indications to various population | • What are the approved indications? |
| • Are there any indications not labeled for the biosimilar but labeled for the originator? | |
| • What are the indications studied in RCTs? | |
| • What indications were approved based on extrapolation only? | |
| • Which population(s) will be using biosimilar? | |
| Product characteristics | Are there notable differences in packaging, labeling or storage in comparison to the reference product? |
| Pharmacoeconomic evaluation | • What is the budget impact of the formulary addition? |
| • Is a cost-minimization analysis necessary? | |
| • Do we need a cost-effectiveness analysis for comparing biosimilars of first-generation biologics vs. second generation reference products? | |
| • Can we expand access to care through the addition of the biosimilar on a budget-neutral basis? | |
| • Are there any unintended direct or in-direct costs that may impact presumed cost savings? | |
| Manufacturing and supply chain | • Will there be a sustainable supply chain and quantities to meet institutional demands? |
| • Does the biosimilar manufacturer have a good track reputation of safety, quality, and meeting demand? | |
| The formulary decision | What are possible critical decisions for regulating use of biosimilars and other formulary biologicals? |
| A thorough review | • Will the biosimilar fully replace the originator, or will both be available at the institution? |
| • Is the approval of the biosimilar a blanket approval for all approved biosimilars available in the market, or specific to one product? | |
| • Will the approved biosimilar be used across all indications to which the reference product was used for? | |
| • If there is an off-label use, will the biosimilar be used in that indication too? | |
| • Is there a need to restrict the biosimilar? Or will current formulary restrictions may change due to lower acquisition cost? | |
| • Is there any specific population in whom the biosimilar may not be suitable for use? | |
| • Will the addition of the biosimilar require updates on drug-use policies or institutional guidelines? | |
| The transition phase | What do we have to consider during formulary transition phase from a reference product to a biosimilar? |
| Adoption | • How will the institution handle the transition phase? |
| • Will specific patients be able to continue treatment with the remaining stocks of the reference product, while new patients start on the biosimilar? | |
| Logistics considerations/information technology support | • What are the current supplies of the reference product and when will the procurement of biosimilar be available? |
| • How will traceability, nomenclature, and coding of biosimilars in electronic medical records (EMR) be arranged? | |
| • Is there a need for mitigation strategies to avoid any inadvertent mix-ups if both biosimilar and reference product are available in hospital? | |
| Biosimilar available | What is next after the biosimilar is available in the formulary? |
| Education | • How Patient education will be arranged? |
| • What are the plans to educate prescribers/other healthcare professionals to enhance the uptake of biosimilars? | |
| Pharmacovigilance | • What processes will there be in place to monitor for the incidence of allergic reactions? |
| • How will loss of efficacy be monitored? | |
| • Will Medication Use Evaluations be necessary? • Will there be specific Therapeutic Drug Monitoring tools? |
|
| • How to handle immunogenicity: will the institution arrange a pathway to provide the reference product on non-formulary basis for patients in case of a significant allergic or immunogenic reaction? |