Ensuring Effective U.S. Biogenerics Legislation: The Cost-Sharing Approach to Compensation for the Cost of Clinical Trials is Preferable to Data Exclusivity

If U.S. policymakers wish to create an additional incentive in biogenerics legislation specifically to cover the cost of the clinical trials required to obtain FDA marketing approval of new biologic drugs, there are approaches — such as sharing the cost of clinical trials — that satisfy the public policy rationale for providing data exclusivity to innovators, at a much lower cost and while avoiding data exclusivity-conferred marketing monopolies that undermine access to medicines and other public health objectives.

If a policy decision were made that innovator companies need investment protections beyond those afforded by the patent system, the cost-sharing approach would be an efficient and pro-public health alternative to the data exclusivity (marketing monopoly) approach. This approach gives generic firms an automatic right to use brand-name originators’ data, but requires them to pay a share of the documented costs of generating the data, proportionate to the size of the markets in which they are selling their product.

Click here to download a fact sheet on this topic:Biogenerics_RD_Cost_Sharing.pdf