GLR Update: The Fate of Follow-On Biologics Remains Uncertain
When the GLR looked last month at the ongoing debate over follow-on biologics, we noted that one of the most contentious issues in creating a regulatory approval pathway for these generic biological drugs centered on the appropriate length of the market exclusivity to be provided to developers of original biologics. Even as we asked the question (Follow-on Biologics: How Much Incentive Do We Need?), it appeared that Congress had its answer, with both the Senate and House health care reform packages containing follow-on biologics provisions that would provide original biologics developers with 12 years of market exclusivity.
A month later, with President Obama pushing for a last-minute reduction in that number (to 10 years, possibly fewer), and with the implications of Scott Brown’s Senate victory still being digested, the picture is considerably murkier. There is no guarantee that there will be follow-on biologics legislation at all, let alone where the final market exclusivity period will wind up.
