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New Paradigm of Biological Products and Harmonization of the Abbreviated Licensing Pathway for Biological Products
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- 발행기관
- 한국생물공학회 바로가기
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- 간행물
- 한국생물공학회 학술대회 바로가기
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- 통권
- 2008 추계학술대회 및 국제심포지움 (2008.10)바로가기
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- 페이지
- pp.24-24
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- 저자
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- 언어
- 영어(ENG)
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- URL
- https://www.earticle.net/Article/A99132
※ 원문제공기관과의 협약기간이 종료되어 열람이 제한될 수 있습니다.
원문정보
초록
- 영어
- The term 'generic' drug is used for chemical drug that are structurally and therapeutically equivalent to an originator product and a regulatory pathway for its approval has been established. However a variety of terms such as 'similar biological medicinal products(biosimilars)', 'follow-on protein products', 'biogenerics', and 'subsequent entry biologics' have been used by different country or region about biological product. And the approach established for small molecule generic product is not appropriate for development, evaluation and licensing of subsequent entry biological product. Because biological product is large and highly complex
molecule that are difficult to characterized. Also structure of the biological product is generally very sensitive to various production parameters such as media, temperature, scale so that it is unlikely that one manufacturer will be able to reproduce biological product manufactured by another company. On the other hand, biological products have been important to treatment of many life-threatening and chronic diseases such as cancer, chronic renal failure, diabetes mellitus. However, there has been a problem with limiting their access to patients because of relatively high cost. Recently the expiration of patents and data protection for the first major group of
innovative biological products that were licensed based on full registration dossier is ushering in an era of subsequent entry biological products. For this reason, subsequent entry biological products are increasingly widen their range and are needed overall regulation and guideline for their evaluation. Therefore KFDA go forward
with preparing the guideline for subsequent entry biological products and harmonize international guideline with it.
키워드
generic similar subsequent entry biological product abbreviate licensing pathway harmonization저자
간행물 정보
발행기관
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- 발행기관명
- 한국생물공학회 [The Korean Society for Biotechnology and Bioengineering]
- 설립연도
- 1984
- 분야
- 공학>생물공학
- 소개
- 이 법인은 생물 공학의 발전과 보급에 이바지하고, 회원 상호 간의 연구 협력과 친목을 도모함을 목적으로 한다 1. 생물공학 분야의 발전을 위한 연구 협력 2. 생물공학의 실용화를 촉진시키기 위한 산학 협동 3. 학술연구 발표회, 강연회, 연수회 등 학술활동의 개최 4. 국,영문 학술지,소식지,학술회의 Proceedings 및 학술도서의 발간 5. 생물공학 발전을 위한 정책 건의 6. 기타 국제 교류 등 본 학회의 목적 달성을 위한 제반 활동
간행물
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- 간행물명
- 한국생물공학회 학술대회
- 간기
- 반년간
- 수록기간
- 1985~2013
- 십진분류
- KDC 476 DDC 576
이 권호 내 다른 논문 / 한국생물공학회 학술대회 2008 추계학술대회 및 국제심포지움
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