Manufacturer | Schering AG, Germany / Berlex, CA, USA | Biogen, France | Ares-Serono, UK |
Approved | 1995 in Europe | 1997 in Europe | 1998 in Europe |
| 1994 in the US | 1996 in the US | 2002 in the US |
Site of production | E coli bacteria cells | Chinese hamster ovary cells | Chinese hamster ovary cells |
Amino acid sequence | Cysteine mutation at position 17 | Identical to human inteferon beta | Identical to human IFNβ |
N-terminal methionine | No | Yes | Yes |
Glycosylated | No | Yes | Yes |
Molecular weight | 18.5 kDa | 22–24 kDa | 22–24 kDa |
Excipients | Human serum albumin, di- and mono-basic sodium phosphate, sodium chloride final pH 7.2 | Human serum albumin, di- and monobasic sodium phosphate, sodium chloride final pH 7.2 | Mannitol, human serum albumin, sodium acetate, acetic acid, sodium chloride, final pH 3.8. |
Therapeutic use | RRMS, secondary progressive MS | RRMS | RRMS |
Therapeutic effect | Decreases frequency and severity of relapses | Decreases frequency of relapses | Decreases frequency and severity of relapses |
| Delay in time to progression of MS | Slows progression of disability | Slows progression of disability |
Therapeutic dose | 250 μg | 30 μg | 22 μg and 44 μg |
Specific activity | 32 MIU/mg | >300 MIU/mg | >300 MIU/mg |
Route of administration | Subcutaneous (SC) only | Intramuscular (IM) only | Subcutaneous (SC) only |
Bioavailability | IM and SC effects similar in duration but different in effect | IM availability is threefold higher than SC | SC and IM produced equivalent exposure to IFNβ |
Frequency of administration | Every other day | Once weekly | Three times per week |
Average weekly dose | 875 μg | 30 μg | 66 μg and 132 μg |
NABs production reported in pivotal clinical trials conducted before drug approval | 45% Reduction in clinical efficacy becoming evident at 18–24 months | 24% in Phase III trial 3–5% in subsequent trials | 12.5–24% after 24 months |
Assay used for NABs analysis | CPE | CPE | CPE |