Follow-on biologics: competition in the biopharmaceutical marketplace.

OBJECTIVE To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. DATA SOURCES A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. STUDY SELECTION Articles pertaining to the follow-on biologic debate. DATA EXTRACTION By the authors. DATA SYNTHESIS Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. CONCLUSION The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.