Room: Phillips 407
Time: Mon 08:30 AM-10:00 AM

Biopharmaceutical Regulation and Competition

Chair: David Ridley (Duke University)

Session Description

We provide economic insights for two of the most important regulatory questions for the biopharmaceutical industry. First, what should be the regulatory environment for generic biologics (also known as biosimilars or follow-on biologics)? Congress is debating how soon after a branded launch a generic biologic manufacturer should be allowed to rely on clinical data from a branded biologic manufacturer. For a pharmaceutical, data exclusivity is 5 years. After 5 years, a generic pharmaceutical manufacturer can use clinical data from a brand-name manufacturer for generic approval. In our session, we will provide economic evidence about the length of data exclusivity required for biologics to break even. We will also describe the competitive environment for biologics and how it differs from pharmaceuticals. A second important regulatory question is whether pharmaceutical manufacturers should be liable for the safety of products approved by the Food and Drug Administration. Recently, the Supreme Court ruled that device makers are not liable for the safety of products approved by FDA, but pharmaceutical makers are liable for the safety of FDA-approved pharmaceuticals. In our session, we will provide economic evidence about the effect of legal liability on social welfare.

Key Terms None

Session Organizer: David Ridley (Duke University)

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Presentations

1. Characterizing Markets for Biopharmaceutical Innovations: Do Biologics Differ from Small Molecules?

   Presenter: Ernst Berndt (Massachusetts Institute of Technology)

   Discussant: Genia Long (Analysis Group, Inc.)

2. Data Exclusivity Periods for Biologics: Maintaining an Appropriate Balance between Short-Term Savings and Long-Term Incentives for Continued Innovation

   Presenter: Henry Grabowski (Duke University)

   Discussant: Scott Harrington (University of Pennsylvania)

3. Tort Liability and the Market for Prescription Drugs

   Presenter: Anup Malani (University of Chicago)

   Discussant: Patricia Danzon (University of Pennsylvania)