ARLINGTON, Va. President Barack Obama’s budget proposal, which includes an approval pathway for biosimilars, won praise from the Generic Pharmaceutical Association last week.
“For patients across the country suffering from cancer, diabetes and other diseases, the support stated by president Obama today for a workable biogenerics approval pathway is lifesaving news,” GPhA president and CEO Kathleen Jaeger said in a statement. “With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed.”
The model that the Hatch-Waxman Act of 1984 established for generic drugs provides a five-year period of data exclusivity for branded pharmaceutical drugs, which GPhA favors for biosimilars as well. However, the Biotechnology Industry Organization favors a 14-year data exclusivity period, saying that the Hatch-Waxman model would not provide sufficient time for biotech companies to recoup research and development expenses, thus stifling innovation.