title: The market for follow-on biologics: how will it evolve?
abstract: With spending on biologics rising and patent expiry approaching for several blockbuster biologics, Congress and the Food and Drug Administration are considering creating a clear pathway for so-called follow-on biologics. Differences between drugs and biologics will affect market outcomes in various ways. Conservative budget impacts are appropriate in the short run because fewer competitors will enter, and average prices will drop less than was the case following the Hatch-Waxman Act. Over the long term, intellectual property provisions will be important considerations for policymakers designing a pathway for follow-on biologics that balances price competition and innovation incentives.
authors.affiliation: Duke University in Durham, North Carolina, USA. grabow@econ.duke.edu
authors.forename: Henry
authors.initials: H
authors.lastname: Grabowski
authors.forename: Iain
authors.initials: I
authors.lastname: Cockburn
authors.forename: Genia
authors.initials: G
authors.lastname: Long
mesh_terms: D001688:Biological Products; D001709:Biotechnology / Q000191:economics* / Q000639:trends; D004345:Drug Industry / Q000191:economics* / Q000639:trends; D006291:Health Policy; D006801:Humans; D010330:Patents as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products