Tied up in the big health care debate are many small duels, some of which will have profound impacts. One of these is "data exclusivity" for biosimilars.
Developing biological drugs, which is the frontier of pharma research, costs bales of money. To make the investments, developers need exclusivity for long enough to recoup the costs. Generic companies, of course, want shorter periods so they can free ride on the investment in research sooner. (You can guess which side I am on -- see Saving the Goose: Intellectual Property and Follow-On Biologics (FOB).)
The pro-developer side won a round
in the Senate this week when the HELP committee voted for a period of
12 years rather than the 7 demanded by the generics and their allies,
such as the FTC and the AARP. (That is one reason I do not belong to
the AARP -- it focuses on price reductions for existing biosimilars
without regard for the health of the overall ecosystem that creates
such drugs. As a senior, I regard that as a definition of the old adage
"penny wise, pound foolish." My interests are aligned with the venture
capitalists, who must have a longer period or they will look for
For an excellent analysis and many links, see Newsfeed Researcher's wrap-up.