New York Congressman Nick Langworthy and Washington Congresswoman Kim Schrier introduced bipartisan legislation July 15 aimed at speeding access to lower-cost alternatives to biologic prescription drugs.
The Expedited Access to Biosimilars Act would clarify that the Food and Drug Administration may approve a biosimilar without additional clinical studies when existing scientific evidence is sufficient. The agency would retain authority to require more studies when necessary for safety and effectiveness.
Biosimilars are alternatives to biologic medicines used to treat conditions including cancer, arthritis, Crohn's disease, diabetes and autoimmune disorders. The FDA must determine that a biosimilar has no clinically meaningful differences from the original medicine in safety or effectiveness.
Langworthy's office said biosimilars typically cost 15% to 35% less than their brand-name counterparts. The lawmakers said additional clinical studies can add costs and delay competition even when existing evidence supports approval.
The bill would also require the FDA to notify manufacturers early in its review if additional clinical studies will be needed.
Langworthy said the measure would reduce duplicative requirements while preserving the FDA's safety standards. Schrier, a physician, said streamlining the approval process could improve access and lower drug prices.
Roswell Park Comprehensive Cancer Center is among the organizations supporting the legislation. Center President and CEO Candace Johnson said biosimilars account for a growing share of therapies used by cancer centers.
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