Federal Trade Commission
The Federal Trade Commission ("FTC" or "Commission") announces it will hold a workshop to explore competition issues involving biologic medicines and follow-on biologics. The workshop will focus on the potential impact of state regulations and naming conventions on such competition, including how regulations may be structured to facilitate competition while still protecting patient health and safety. The experience of developing follow-on competition from small-molecule generic drugs will be considered and, as relevant, compared. Topics will include the circumstances under which potential entrants would be willing to invest in the development of follow-on biologics in order to use the abbreviated regulatory approval pathway created by federal legislation. The workshop will also survey the experience of other countries with regulatory systems that enable follow-on biologic competition. This Notice poses a series of questions about which the FTC seeks public comment. The FTC will take these comments into account in its examination of these topics.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Federal Trade Commission AGENCY: Federal Trade Commission. ACTION: Notice of workshop and request for comments. SUMMARY: The Federal Trade Commission (“FTC” or “Commission”) announces it will hold a workshop to explore competition issues involving biologic medicines and follow-on biologics. The workshop will focus on the potential impact of state regulations and naming conventions on such competition, including how regulations may be structured to facilitate competition while still protecting patient health and safety. The experience of developing follow-on competition from small-molecule generic drugs will be considered and, as relevant, compared. Topics will include the circumstances under which potential entrants would be willing to invest in the development of follow-on biologics in order to use the abbreviated regulatory approval pathway created by federal legislation. The workshop will also survey the experience of other countries with regulatory systems that enable follow-on biologic competition. This Notice poses a series of questions about which the FTC seeks public comment. The FTC will take these comments into account in its examination of these topics. DATES: The workshop will be held on December 10, 2013, in the FTC headquarters at 600 Pennsylvania Avenue NW., Washington, DC. The FTC workshop is free and open to the public and will also be webcast. Prior to the workshop, the Commission will publish an agenda and further information on its …
Citation: 78 FR 68840
