New Democrat Coalition supports H.R. 1548

WASHINGTON Leaders of the New Democrat Coalition voted Thursday to endorse a biosimilars bill introduced as an alternative to a bill that would use the Hatch-Waxman Act of 1984 as a model.

H.R. 1548, the Pathway for Biosimilars Act, introduced by fellow New Democrat Reps. Anna Eshoo of California and Jay Inslee of Washington, would allow a regulatory pathway for biosimilars but allow 14 years of market exclusivity, compared with the five-year period allowed by a bill introduced earlier by Rep. Henry Waxman, D-Calif.

“America’s patients want new cures, and they deserve access to cheaper medicines,” New Democrat chairwoman Rep. Ellen Tauscher of California said. “That’s why the Food and Drug Administration needs the authority to approve follow-on biologics.”

The bill, introduced on March 17, competes with Waxman’s Promoting Innovation and Access to Life-Saving Medicine Act, introduced on March 11, along with a companion bill introduced in the Senate on March 26. The Generic Pharmaceutical Association supports the Waxman bill, while the Biotechnology Industry Organization supports the Eshoo bill.

In other news, Sen. Orrin Hatch, R-Utah, who co-sponsored the Hatch-Waxman Act that made generic pharmaceutical drugs possible, broke with Waxman in telling reporters at drug regulation conference that he and Sen. Ted Kennedy, D-Mass., support longer exclusivity periods for biosimilars, according to published reports.