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An Analysis of Follow-On Development in New Drug Classes, January 1986-June 2018.
Lanthier, Michael L; Kerr, Kirk W; Miller, Kathleen L.
Afiliación
  • Lanthier ML; Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kerr KW; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Miller KL; Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 106(5): 1125-1132, 2019 11.
Article en En | MEDLINE | ID: mdl-31206617
Follow-on drugs-new medicines approved within an established drug class-provide incremental treatment improvements, additional choices for clinicians and patients, and potential price competition. We examine the timing, quantity, and product characteristics of within-class drug approvals for new drug classes approved by the US Food and Drug Administration since January 1986. We find that nearly two-thirds of first-in-class drugs do not face a subsequent follow-on product. Follow-on innovation within a drug class was more common and occurred more rapidly in the 1990s than during the 2000s. We also find that fewer drug classes have multiple competitors entering the market during the 2000s. First-in-class drugs treating rare disorders experienced lower rates of follow-on entry than drugs treating common medical conditions. The decreased pace of follow-on development likely results from greater industry focus on rare diseases and increasing reimbursement pressure on products lacking clear advantages over existing products.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Aprobación de Drogas / Industria Farmacéutica Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Aprobación de Drogas / Industria Farmacéutica Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos