With President Obama once again making waves about speeding up the delivery of less expensive follow-on biologics as a tool to rein in health care costs, the head of the FDA is vowing to wrap up work on the agency's approval pathway for the biosimilar sector.
"This is critically important," FDA commissioner Margaret Hamburg tells Bloomberg. "We obviously have been thinking about this for some time as different models have been discussed and debated. We will be more formally implementing in the very near-term time frame."
The biotech industry has been closely focused on these new rules for developing biosimilars; copies of complex therapeutics. The FDA needs to clarify exactly how extensive clinical trials will need to be on the second-gen follow-ons, which will initially focus on some low hanging fruit in the anemia arena before moving on to blockbuster antibodies now marketed by Roche and others.
Most analysts expect that these new biosimilar programs will be restricted to a handful of developers with very deep pockets. The programs will likely require expensive late-stage trials, excluding a host of small biotechs which are focused on early and mid-stage work.
- here's the story from Bloomberg