TABLE 5.
Measures to endorse the use of biosimilar medicines at community pharmacy.
| Country | Biosimilar substitution | Generic susbstitution | Financial incentives to dispense biosimilars | |
|---|---|---|---|---|
| Applied | Bindingness | Bindingness | ||
| AT | No | Not allowed | Not allowed | No financial incentives |
| BE | No | Not allowed | Yes, voluntary in general (mandatory for antibiotics and antimycotics) | No financial incentives |
| CZ | Yes | Not explicitly prohibited, but not recommended by physicians and pharmacists | Yes, voluntary | N.A. |
| DE | No | As of 2022 substitution takes place automatically provided that the Federal Joint Committee has determined interchangeability | Yes, mandatory | No financial incentives |
| DK | No | Not allowed | Yes, mandatory | No financial incentives |
| ES | No | Not allowed | Yes, mandatory | No financial incentives |
| FI | No | Not allowed | Yes, mandatory | No financial incentives |
| FR | No | Not allowed (legal mandate as of 2014 to implement biosimilar substitution) was abolished in the 2020 Social Insurance law | Yes, voluntary | Yes, as part of the pharmacy mark-up regulation |
| IE | No | Not allowed | Yes, voluntary | No financial incentives |
| IT | No | Not allowed | Yes, mandatory | No financial incentives (higher wholesale and pharmacy margins for generics than for originators and biosimilars) |
| NL | No | Not allowed | Yes, voluntary | No financial incentives |
| NO | No | Not allowed a | Yes, voluntary | No information on financial incentives |
| PT | No | Not allowed | Yes, mandatory (with exceptions defined in law) | No financial incentives |
| SE | No | Not allowed | Yes, mandatory | No financial incentives |
| SK | No | Not allowed b | Yes, mandatory | N.A. |
| UK | No | Not allowed | Not allowed | No financial incentives |
N.A. = no information available.
a
As of July 2020, a public consultation of the Ministry of Health and Social Affairs to possibly introduce biosimilar substitution is ongoing.
b
Substitution regulation does not differ between generics and biosimilars. However, the statutory list of active substances, which are subject to mandatory substitution, does not include any biological.