Biosimilars bill passed by House committee draws response from GPhA

NEW YORK A House committee vote has brought a pathway for biosimilars one step closer to reality, but not in a way that pleases everyone.

The House Energy and Commerce Committee voted 47-11 Friday to pass an amendment to the healthcare reform bill that would give biotech drugs 12 years of market exclusivity before they face competition from biosimilars.

“We are sincerely disappointed that some members of the House Energy and Commerce Committee have decided to put brand pharmaceutical profits before patient needs,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger said in a statement. “The amendment passed tosses patient needs out the window.”

In March, Reps. Henry Waxman and Anna Eshoo, both California Democrats, sponsored competing bills in Congress to allow a regulatory pathway for biosimilars. Waxman’s bill would give biotech drugs five years’ market exclusivity before facing biosimilar competition, like the Hatch-Waxman Act of 1984, which created a pathway for generic pharmaceutical drugs. Eshoo’s bill would grant 12 to 14 years of exclusivity. The short-exclusivity plan has the support of the generic drug industry, patient advocates, pharmacy trade groups and The Washington Post editorial page, though legislation to allow longer exclusivity periods has advanced further in the House and Senate.