2018년 7월 19일, FDA(미국식품의약국)에서 바이오시밀러 활성정책 발표
  • 11페이지 분량의 FDA 바이오시밀러 활성정책 (FDA Biosimilars Action Plan)자료 공개
  • 활성정책 11가지 발표
  • 바이오시밀러는 의약품 가격을 낮추는 하나의 방법임
  • FDA는 2018 년까지 11 개의 바이오시밀러를 승인했지만 현재 미국에서만 3 개가 시판되고 있음
  • 바이오시밀러 약들이 알맞은 시기에 출시가 되었다면 45억달러 (약 5조원)정도 의약품 비용이 절감되었을 것이라고 추정
  • FDA에서는 OECD 대상으로 바이오시밀러 경쟁분석을 하였는데, 조만간 이 내용을 공개할 예정
11가지 활성화 정책 (Action Plan)
  1. Developing and implementing new FDA review tools, such as standardized review templates that are tailored to marketing applications for biosimilar and interchangeable products, to improve the efficiency of FDA review and enhance the public information about FDA’s evaluation of these products.
  2. Creating information resources and development tools for sponsors of biosimilar applications. This includes tools such as in silico models and simulations to correlate pharmacokinetic and pharmacodynamic responses with clinical performance. Such tools can make biosimilar drug development more efficient.
  3. Enhancing the Purple Book to include more information about approved biological products, including information relating to reference product exclusivity determinations.
  4. Actively exploring the potential for entering into new data sharing agreements with foreign regulators to facilitate the increased use of non-U.S.-licensed comparator products in certain studies to support a biosimilar application.
  5. Establishing a new Office of Therapeutic Biologics and Biosimilars (OTBB) to improve coordination and support of activities under the Biosimilar User Fee Act (BsUFA) program, accelerate responses to stakeholders and support efficient operation and policy development.
  6. Building on the FDA’s Biosimilar Education and Outreach Campaign, continue providing critical education to health care professionals, including releasing a series of videos that explain key concepts about biosimilar and interchangeable products.
  7. Publishing final or revised draft guidance on biosimilar product labeling to assist sponsors in determining what data and information should be included in the labeling.
  8. Providing additional clarity for product developers on demonstrating interchangeability, including by publishing final or revised draft guidance.
  9. providing additional clarity and flexibility for product developers on analytical approaches to evaluating product structure and function to support a demonstration of biosimilarity, including by publishing revised draft guidance on the use of data analysis methods, including statistical approaches.
  10. Providing additional support for product developers regarding product quality and manufacturing process, including by identifying physical product quality attributes that are most critical to evaluate, and by exploring ways to reduce the number of lots of the reference product required for testing.
  11. Engaging in a public dialogue through a Part 15 hearing and opening a docket to request additional information from the public on what additional policy steps the FDA should consider as we seek to enhance our biosimilar program
 

FDA 원문

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
(원문 오른쪽에서 FDA : Biosimilars Action Plan 문서 다운 가능)

관련 국내기사

FDA, 바이오시밀러 활성정책 공개…’해외 임상자료 인정’
“美 바이오시밀러 활성화 정책 발표, 허가 수월해질 것”-유진

관련 해외기사

FDA Releases Biosimilar Action Plan
FDA Reveals Biosimilar Plan; Gottlieb Blasts Delays