Yanet Hechavarría Núñez,Rodrigo Omar Pérez Massipe,Santa Deybis Orta Hernández et al.
Yanet Hechavarría Núñez et al.
Biopharmaceuticals make up a significant proportion of medicinal products used for the treatment of diseases such as cancer, arthritis, cardiac dysfunctions and AIDS. Access to therapies based on the use of these products has been limited a...
Evaluation of similar biotherapeutic products: scientific and regulatory challenges [0.03%]
相似生物制品的评价：科学和监管方面的挑战
Elwyn Griffiths,Robin Thorpe,Meenu Wadhwa et al.
Elwyn Griffiths et al.
Ivana Knezevic,Elwyn Griffiths
Ivana Knezevic
Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolongin...
Chenggang Liang,Junzhi Wang
Chenggang Liang
In order to ensure most Chinese patients, particularly in the population with relatively low incomes, have access to safe, low cost, effective and quality-assured medicines, a number of "stand-alone" biological products, which have good qua...
Towards regulation of similar biotherapeutic products: Thailand's perspective [0.03%]
从泰国的视角看类似生物药监管体系的构建与发展
Prapassorn Thanaphollert,Kriang Tungsanga
Prapassorn Thanaphollert
The implementation of universal health coverage scheme in Thailand allows quality, equitable and accessible health care for all. Patients with life threatening and chronic diseases can get access to biotherapeutic products to treat their ai...
Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan [0.03%]
日本重组人生长激素和重组人促红细胞生成素类似药仿制评价的体会
Teruyo Arato,Teruhide Yamaguchi
Teruyo Arato
To share the experience of reviewing clinical data required for the licensing of follow-on biologic products (biosimilar products and similar biotherapeutical products as EU and WHO terminology, respectively) in Japan, the data packages of ...
Clinical programs in the development of similar biotherapeutic products: rationale and general principles [0.03%]
类似生物制品临床研发程序的理沦与基本原则
Alexander Berghout
Alexander Berghout
Similar biotherapeutic products (SBPs) or biosimilars are biologics developed by pharmaceutical manufacturers to match originator biologics that have been on the market for a long time and lost their exclusivity (patent and market protectio...
Evaluation of similar biotherapeutic products (SBPs): scientific principles and their implementation [0.03%]
类似生物药产品(EVALSBP)评价：科学原则及其应用
Ivana Knezevic
Ivana Knezevic
The availability of biotherapeutic products to patients has a major impact on the success in treating many life-threatening and chronic diseases. These products are often derived by recombinant DNA technology and are expensive for the major...
WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010 [0.03%]
世卫组织/韩国食品药品管理局联合研讨会将于2010年8月24日至26日在韩国首尔举行：实施《评估类似生物药指南》
Meenu Wadhwa,Hye-Na Kang,Ivana Knezevic et al.
Meenu Wadhwa et al.
In August 2010, the World Health Organization and the Korea Food & Drug Administration jointly organized the first implementation workshop of WHO guidelines on evaluating similar biotherapeutic products (SBPs) at the global level. The objec...
Teruhide Yamaguchi,Teruyo Arato
Teruhide Yamaguchi
Recently, WHO, EU, Japan and Canada have published guidelines on biosimilar/follow-on biologics. While there seems to be no significant difference in the general concept in these guidelines, the data to be submitted for product approval are...