Scholarlink

<p>The article review the challenges and lack of robust biologics market competition and drug pricing impacts, the history of the small molecule generics marketplace and the subsequent early evolution of the biosimilar marketplace. The article then explores the potential of an abbreviated biologics license application pathway to market—akin to the market entry pathway for generics—as a policy lever for improving biologics drug price competition, drug affordability and expanded access.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

The Future of Biologics: Lessons from Hatch–Waxman

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月7日

查看全文
  • Brian J. Miller,
  • Janet Woodcock

摘要

The article review the challenges and lack of robust biologics market competition and drug pricing impacts, the history of the small molecule generics marketplace and the subsequent early evolution of the biosimilar marketplace. The article then explores the potential of an abbreviated biologics license application pathway to market—akin to the market entry pathway for generics—as a policy lever for improving biologics drug price competition, drug affordability and expanded access.