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<p>Multiple high-cost dermatologic drugs may lose patent protection and/or market exclusivity between 2027 and 2037. While the resulting introduction of generics and biosimilars has the potential to improve affordability and expand patient access, real-world uptake remains variable and is shaped by complex regulatory, payer, and market dynamics. This review synthesizes current clinical, regulatory, and health policy literature to examine U.S. factors influencing generic and biosimilar adoption in dermatology and to contextualize these challenges within the upcoming patent cliff. Generics often capture substantial market share shortly after FDA approval, whereas biosimilars face barriers due to distinct approval pathways and substitution policies, among other factors. Additional obstacles—such as formulary exclusions, patent evergreening, prior authorizations, and step therapy—further delay patient access, increase clinician burden, and worsen outcomes. Patient and provider hesitancy regarding safety, efficacy, and interchangeability further constrains uptake. As dermatology approaches a period of significant therapeutic transition, proactive clinician engagement, regulatory alignment, and targeted education will be essential to translate upcoming patent/exclusivity expirations into durable improvements in access, affordability, and quality of care.</p>

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Facing the patent cliff: the implications of anticipated biologic and systemic drug patent expirations in dermatology

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年6月29日

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  • Ngoc-Trang Adrienne H. Nguyen,
  • Howard P. Forman,
  • John S. Barbieri,
  • Harrison P. Nguyen

摘要

Multiple high-cost dermatologic drugs may lose patent protection and/or market exclusivity between 2027 and 2037. While the resulting introduction of generics and biosimilars has the potential to improve affordability and expand patient access, real-world uptake remains variable and is shaped by complex regulatory, payer, and market dynamics. This review synthesizes current clinical, regulatory, and health policy literature to examine U.S. factors influencing generic and biosimilar adoption in dermatology and to contextualize these challenges within the upcoming patent cliff. Generics often capture substantial market share shortly after FDA approval, whereas biosimilars face barriers due to distinct approval pathways and substitution policies, among other factors. Additional obstacles—such as formulary exclusions, patent evergreening, prior authorizations, and step therapy—further delay patient access, increase clinician burden, and worsen outcomes. Patient and provider hesitancy regarding safety, efficacy, and interchangeability further constrains uptake. As dermatology approaches a period of significant therapeutic transition, proactive clinician engagement, regulatory alignment, and targeted education will be essential to translate upcoming patent/exclusivity expirations into durable improvements in access, affordability, and quality of care.