TABLE 1.
Biosimilar policy landscape in selected countries in 2021.
| Policy | AUS | BEL | BRA | CAN | FRA | DEU | GBR | ITA | JPN | MEX | NLD | NOR | SAU | ESP | CHE | UAE | United States |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturing and R&D | |||||||||||||||||
| - Local manufacturing incentives | X | X | X | ||||||||||||||
| - Early biosimilar manufacturing license | X | X | X | X | X | X | X | X | X | X | |||||||
| Regulatory approval | |||||||||||||||||
| - Streamlined evidence requirements | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| - Simplified regulatory approval through international collaboration | X | ||||||||||||||||
| - Regulatory support for biosimilar submission | X | ||||||||||||||||
| Health technology assessment | |||||||||||||||||
| - Lack of full-length health technology assessment requirements for biosimilars | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
| - Simplified health technology assessment submission requirements | X | X | |||||||||||||||
| Pricing | |||||||||||||||||
| - At launch—mandated fixed discounts for biosimilars | X | X | X | X | X | X | X | ||||||||||
| - At launch—mandated fixed discounts for originators | X | X | X | X | X | ||||||||||||
| - At launch—tiered discounts for biosimilars | X | ||||||||||||||||
| - Over time—progressive price discounts | X | X | X | ||||||||||||||
| - At launch—reference pricing mechanisms | X | X | X | X | X | X | X | X | X | X | |||||||
| Reimbursement | |||||||||||||||||
| - Automatic reimbursement following regulatory approval and submission | X | X | X | X | X | X | X | X | X | ||||||||
| - Full versus partial coverage | X | X | X | X | X | X | X | ||||||||||
| - Exclusionary contracts | X | ||||||||||||||||
| Contracting | |||||||||||||||||
| - Direct contracting with providers | X | X | X | X | X | X | X | X | |||||||||
| - Tendering practices | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
| Biosimilar education and understanding | |||||||||||||||||
| - Healthcare professional educational programs | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
| - Patient educational programs | X | X | X | X | X | X | X | X | X | X | |||||||
| Prescribing | |||||||||||||||||
| - Clinical recommendations for prescriber-initiated biosimilar prescription | X | X | X | X | X | X | X | X | X | X | |||||||
| - Mandated switching to cheapest alternative | X | X | |||||||||||||||
| - Prescription quotas for volume of biosimilar prescription | X | X | X | X | X | X | |||||||||||
| - Financial incentives linked to volume of biosimilar prescription | X | X | X | X | X | X | |||||||||||
| - Financial penalties linked to volume of biosimilar prescription | X | ||||||||||||||||
| - De facto prescribing by international non-proprietary name | X | X | X | X | |||||||||||||
| Dispensing | |||||||||||||||||
| - Automatic substitution | X | X | X | X | |||||||||||||
| - Regressive pharmacist markups | X | X | X | X | X | X | X | X | |||||||||
| - Reduced patient co-payments | X | ||||||||||||||||
| Monitoring | |||||||||||||||||
| - Post-commercialisation pharmacovigilance measures | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| - Supply and usage monitoring | X | X | X | ||||||||||||||
Note: “X” = policy applied in the country.