Spend Less? Congress May Like Biosimilars

Think that biosimilar legislation will go nowhere this year? Think again. The potential for biosimilars to lower Medicare and Medicaid drug spending could spark support for a follow-on biologics bill this year, if lowered expenditures could offset higher spending elsewhere, FDA Legislative Watch reports.

Under rules that the House applies to pending legislation, any new spending under a bill must be matched by a cut elsewhere or by a tax increase, the newsletter notes. But legislators eyeing new projects at FDA or NIH, for example, could “look to a bill like this and have a five-year savings that matches the five-year spending,” David Schmickel of the Senate Health, Education, Labor and Pensions committee told an industry conference. “That’s motivation for a lot of members to get these things done.”

Any proposal that might decrease spending “is big news in Congress,” Lisa Layman, a former Senate staffer who now lobbies for the Generic Pharmaceutical Association, told the crowd. “There are a lot of people for whom the savings are important - legislators who are struggling with the deficit and federal health programs, as well as patients.”

One bill was introduced last month that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, plus an extra two years for a medically significant innovation. The BIO trade group was effusive in its support; the generic trade group called it a “step backwards.”