GENERIC BIOLOGICS COULD SAVE $71 BILLION OVER 10 YEARS, REPORT SAYS

A pathway for creating and marketing generic biologics could help health plan sponsors and patients save $71 billion over the next 10 years, according to an Express Scripts report.

The FDA should release guidelines for the approval of generic biologics, the report said. Patient and insurer savings could reach $3.5 billion in savings the first year generic alternatives are on the market, the report added.

Express Scripts said it supports H.R.1038, the "Access to Life-Saving Medicine Act of 2007," which may be attached to the Prescription Drug User Fee Act reauthorization. The bill would establish a statutory pathway for the FDA to approve biologic license applications by giving the agency a way to measure the comparability of a biogeneric drug to its reference product without drug companies having to conduct costly and duplicative clinical trials.

The company's report drew on a review of four biologic drug classes in which key patents have expired — treatments for multiple sclerosis, anemia, growth hormone deficiencies and diabetes. The largest savings would come from anemia treatments, totaling $40.7 billion over 10 years, the report said.

Eighty percent of patients with a growth hormone deficiency could switch to a generic biologic, saving $27.7 million in the first year, according to the report. Half of multiple sclerosis patients could switch, saving $678 million in the first year, and more than 25 percent of patients with diabetes could use a generic product and save $797 million.