Biogenerics could save US $6.6B over 10 years

The USA's Congressional Budget Office released a long-awaited cost analysis, which found that the creation of an abbreviated pathway for follow-on biologics - or biogenerics - would save the federal government $6.6 billion over 10 years and lower total expenditures for biologics by $25.0 billion over the same time period.

The issue of creating such as system has already been the subject of much debate and comment from the US administration, the research-based pharmaceutical and biotechnology industries, as well as the makers of generic medicines, especially given that the European Union has managed to come up with a solution and clear several biosimilar compounds (Marketletters passim).

Two House bills have been put forward to approve copy versions of biological drugs, but there are still unresolved issues. For example, the Biotechnology Industry Association is pushing for legislation, but wants a 12-year data exclusivity period, while the copy drugmakers are calling for a lot less.