The House Judiciary Committee has voted in favor of H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act. The Bill was also referred to the House Energy & Commerce Committee and so may have a few more hurdles before it moves to the House Floor.
The key aspect of the proposal is to create a presumption of anticompetitive behavior anytime a generic ANDA/biosimilar filer “receives anything of value” while also agreeing to forgo any “research, development, manufacturing, marketing, or sales of the ANDA product or biosimilar biological product.” The proposal appears to limit use of this presumption only to situations where the FTC brings an action, and not a private antitrust claim.
A parallel bill proposed by Sen. Klobuchar is pending in the Senate.