UPDATE: US biotech's 14-years data exclusivity pre-biogenerics claim "is flawed"

The contentious issue of follow-on biologics - or biogenerics - in the USA, has hit the headlines again with an economist finding flaws in the 14-year data exclusivity claim requirement of the research-based biotechnology and pharmaceutical industry (Marketletters passim).

A white paper released by Alex Brill, a former House Ways and Means Committee chief economist and senior advisor, who is currently a research fellow at the American Enterprise Institute, found that a sufficient data exclusivity period to grant brand biologics manufacturers before biogenerics can come to market is seven years, rather than the 14 years currently supported by the Biotechnology Industry Organization.

Mr Brill's analysis, commissioned by Teva Pharmaceuticals USA, a subsidiary of Israel-headquartered global generics leader Teva, was released as a newly-elected Congress and Administration are poised to create a pathway for the approval of biogenerics that is expected to generate significant cost savings for the American health care system. Earlier this year, the US Congressional Budget Office released a long-awaited cost analysis, which found that the creation of an abbreviated pathway for the approval of biogenerics could 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 (Marketletter July 7).