Table 1.
Key differences between WHO, FDA and EMA biosimilar guidelines
| WHO1 | FDA2 | EMA3 | |
|---|---|---|---|
| Definition | A biosimilar should be compared to an RP licensed in the same jurisdiction | A US biosimilar must be compared with an RP licensed in the US | An EU biosimilar must be compared with an RP licensed in the EU |
| Nomenclaturea | Standardized INNs should be used to identify an RP, followed by a four letter suffix to identify its biosimilar (eg, etanercept and etanercept‐szzs) | As per WHO guidelines | Proprietary names should clearly distinguish between the RP and its biosimilar without indicating similarities (eg, the RP for etanercept is Enbrel and its biosimilar is Benepali) |
| Interchangeability | No formal demonstration of interchangeability is required | Interchangeability must be demonstrated in ≥1 clinical study involving ≥3 switches between the biosimilar and its RP | No formal demonstration of interchangeability is required |
| Biosimilar/RP switching policy | No specific recommendations; individual member states should make their own policies | Refer to “The Purple book” (a comprehensive list of biologics with information on biosimilarity and interchangeability) | Each biosimilar is unique; refer to molecule‐specific guidance documents |
Abbreviations: EMA, European Medicines Agency; FDA, US Food and Drug Administration; INN, International Non‐proprietary Name; RP, reference product; WHO, World Health Organization.
a
Individual countries often develop their own systems.