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Aug 12, 2002
 |  BioCentury  |  Regulation

The Avonex approval

Biogeneric Science

The Avonex approval

Few compounds showcase as many facets of the biogenerics argument as interferon beta. There are three IFN betas on the market - Avonex IFN beta-1a from Biogen Inc., Rebif interferon beta-1a from Serono (SRA; SWX:SEO, Geneva, Switzerland), and Betaseron interferon beta-1b from Schering AG (FSE:SCH; SHR, Berlin, Germany).

Compositional differences between the three interferons appear to be reflected in their different clinical profiles (see BioCentury, March l8). For example, Betaseron, produced in E. coli, is not glycosylated and has a reduced affinity for IFN beta receptors compared to the glycosylated products Rebif and Avonex.

This translates into an activity of 32 million international units (IU)/mg of Betaseron. This measure of activity is derived by comparing the antiviral activity of Betaseron to the World Health Organization standard for recombinant IFN beta. In contrast, Avonex has an activity of 200 million IU/mg. As a result, Avonex is...

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