Table 1.
Clinical study recommendations for biosimilars of different product classes.
Source: European Public Assessment Reports and guidelines
| Substance | Structure of protein | Molecular mass (kDa) | Current clinical study recommendations |
|---|---|---|---|
| Teriparatide | Single-chain, non-glycosylated | 3.7 |
PK/PD study in HV No efficacy/safety trial |
| Low-molecular-weight heparin | Polysaccharide chain | 4.5 |
PK/PD study in HV No efficacy trial Safety/immunogenicity study may be waived |
| Insulin | Two-chains, non-glycosylated | 6 |
PK/PD (clamp) study in HV or patients with T1DM No efficacy trial Safety/immunogenicity study may be waived |
| (Peg)filgrastim | Single-chain, non-glycosylated (pegylated) | 20 |
PK/PD study in HV No efficacy trial Safety/immunogenicity study may be waived |
| Interferon-β | Single-chain, non-glycosylated | 20 |
PK/PD study in HV Efficacy/safety trial in patients with MS using MRI-related efficacy endpoint |
| Somatropin | Single-chain, non-glycosylated | 22 |
PK/PD study in HV Efficacy/safety trial in children with growth hormone deficiency using height velocity as efficacy endpoint |
| Follitropin-α | Two-chains, glycosylated | 23 |
PK/PD study in HV Efficacy/safety trial in patients undergoing superovulation for ART using ‘number of oocytes retrieved’ as efficacy endpoint |
| Epoetin | Four helices, extensively glycosylated | 34 |
PK/PD study in HV Efficacy/safety trial in patients with renal anaemia using haemoglobin as efficacy endpoint |
| Etanercept | VEGF-Fc complex 4-chain fusion protein, glycosylated | 130 |
PK study in HV Efficacy/safety trial in patients with RA using ACR20 or DAS28 as primary efficacy endpoint |
| Infliximab | Complex 4 chains, glycosylated | 165 |
PK study in HV Efficacy/safety trial in patients in a therapeutic indication approved for the reference medicine, which is sensitive to detect potential differences |
| Bevacizumab | 149 | ||
| Adalimumab | 150 | ||
| Trastuzumab | 145 | ||
| Rituximab | Complex 4 chains, glycosylated | 144 | PK study in one therapeutic area plus efficacy/safety trial (plus PK data) in the other therapeutic area |
Bold copy indicates instances when trials are not required or may be waived
ACR20 improvement of 20% according to criteria of the American College of Rheumatology, ART assisted reproductive treatment, DAS28 Disease Activity Score based on evaluation of 28 joints, HV healthy volunteers, MRI magnetic resonance imaging, MS multiple sclerosis, PD pharmacodynamic, PK pharmacokinetics, RA rheumatoid arthritis, T1DM type 1 diabetes mellitus, VEGF vascular endothelial growth factor