Scholarlink

Background <p>In 2019, the US Food and Drug Administration (FDA) finalized guidance for designating interchangeable biosimilars requiring pre-approval phase III clinical trials to evaluate safety when reference and biosimilar formulations are interchanged. In June 2024, Draft FDA Guidance on interchangeability relaxes FDA approval criteria focusing on analytic rather than clinical findings. This study examines US trends in interchangeable biosimilar approvals between 2019 and 2025, manufacturer strategies, and regulatory timelines.</p> Methods <p>We used the FDA Purple Book archive (September 2025) to identify interchangeable biosimilars, associated Biologic License Application (BLA) numbers, manufacturers, reference products, and FDA approval dates. FDA submission dates were obtained from FDA approval letters. We analyzed trends by year, manufacturer, product, and product class to assess patterns in approval timing and strategy.</p> Results <p>Since 2020, the FDA has approved 26 interchangeable biosimilars, with 19 approved between January 2024 and September 2025. Six are adalimumab biosimilars. Manufacturers employed two strategies: concurrent submission for interchangeability (17 cases) or delayed pursuit (9 cases). Average approval timelines decreased from 798 days for applications dated in 2020 to 364 days for applications dated in 2024. All interchangeable biosimilars completed pre-approval switching studies.</p> Conclusions <p>Concurrent interchangeable designation is now the predominant regulatory pathway. The FDA June 2024 Draft Guidance, removing switching studies requirement for interchangeability might cut biosimilar development costs and development timelines. These changes, alongside provider and patient education, could enhance biosimilar uptake and reduce biologic drug costs.</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

Regulatory Requirements for Interchangeable Biosimilar Designation

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月16日

查看全文
  • Praveen J. Samy,
  • Morgane C. Mouslim,
  • Charles L. Bennett,
  • Antonio J. Trujillo

摘要

Background

In 2019, the US Food and Drug Administration (FDA) finalized guidance for designating interchangeable biosimilars requiring pre-approval phase III clinical trials to evaluate safety when reference and biosimilar formulations are interchanged. In June 2024, Draft FDA Guidance on interchangeability relaxes FDA approval criteria focusing on analytic rather than clinical findings. This study examines US trends in interchangeable biosimilar approvals between 2019 and 2025, manufacturer strategies, and regulatory timelines.

Methods

We used the FDA Purple Book archive (September 2025) to identify interchangeable biosimilars, associated Biologic License Application (BLA) numbers, manufacturers, reference products, and FDA approval dates. FDA submission dates were obtained from FDA approval letters. We analyzed trends by year, manufacturer, product, and product class to assess patterns in approval timing and strategy.

Results

Since 2020, the FDA has approved 26 interchangeable biosimilars, with 19 approved between January 2024 and September 2025. Six are adalimumab biosimilars. Manufacturers employed two strategies: concurrent submission for interchangeability (17 cases) or delayed pursuit (9 cases). Average approval timelines decreased from 798 days for applications dated in 2020 to 364 days for applications dated in 2024. All interchangeable biosimilars completed pre-approval switching studies.

Conclusions

Concurrent interchangeable designation is now the predominant regulatory pathway. The FDA June 2024 Draft Guidance, removing switching studies requirement for interchangeability might cut biosimilar development costs and development timelines. These changes, alongside provider and patient education, could enhance biosimilar uptake and reduce biologic drug costs.