Putting the kibosh on Waxman
Edward Kennedy and Orrin Hatch, two senators whose views on the topic will be decisive, made it clear last week that legislation creating a pathway for FDA approval of follow-on biologics will be enacted, but it won't be the bill the generic drug industry has been lobbying for.
Kennedy (D-Mass.) and Hatch (R-Utah) expressed interest in emulating the European biosimilars framework, an approach that several biotech companies have been advocating in lobbying sessions with congressional staff.
Speaking last week at a hearing on FOBs held by the Senate Health, Education, Labor and Pensions (HELP) Committee, Hatch said he could not support the Access to Life-Saving Medicine Act (H.R. 1038/S. 623) that was drafted by Rep.