Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars) [0.03%]
参考药物及世卫组织国际标准/参考试剂在生物类似药开发中的用途
Robin Thorpe,Meenu Wadhwa
Robin Thorpe
Reference Products and WHO International Standards/Reference Reagents have roles to play in the development and characterization of similar biological products (SBPs). However, these roles are distinct and non-interchangeable. The uses of t...
Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010) [0.03%]
选报国家类似生物药情况概述(2010年8月)
Hye-Na Kang
Hye-Na Kang
The WHO guidelines on evaluating similar biotherapeutic products (SBPs) were adopted by the Expert Committee on Biological Standardization in 2009. The fundamental messages of the guidelines are that a) generic approach is not suitable for ...
Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches [0.03%]
生物类似药临床研发方案：确证性临床试验：等效和非劣效方法比较的虚拟/模拟案例研究
Mark P Fletcher
Mark P Fletcher
As part of long term commitment of the Biologicals and Vaccines Committee (B&V) of the International Federation of Pharmaceutical Manufacturers and Association (IFPMA) to provide expert input to the WHO on their recently finalized GUIDELINE...
Rania Dakhlallah Haddadin
Rania Dakhlallah Haddadin
After the expiration of patents on originator biological products, Jordanian local manufacturers and the agents of international pharmaceutical companies in Jordan started to submit registration dossiers for biosimilar products. The Jordan ...
Biotechnological products in Pan American Health Organization (PAHO): regional efforts towards harmonization of regulation [0.03%]
泛美卫生组织(PAHO)生物制品区域协调努力项目概述
María L Pombo
María L Pombo
Current regulatory and scientific considerations for approving biosimilars in Iran [0.03%]
伊朗批准生物类似药的现行监管和科学考量因素
Naser Hadavand,Mahboubeh Valadkhani,Aida Zarbakhsh
Naser Hadavand
With the expiration of patents on the first generation of rDNA biopharmaceuticals, competitors began to introduce biosimilar products. The concept of generics as applied to classical chemical drugs cannot be used for biotechnology products....
Similar biological medicinal products currently licensed in the European union--overview of non-clinical study programs [0.03%]
目前欧盟批准的生物类似药的非临床研究项目概述
Hans-Karl Heim
Hans-Karl Heim
In the EU, a regulatory framework has been established which defines general conditions for marketing authorisation approval of similar biological medicinal products (SBMPs). In addition, the framework provides product-class specific recomm...
Gamma irradiation of animal sera for inactivation of viruses and mollicutes--a review [0.03%]
动物血清的γ射线辐照灭活病毒和柔膜菌群的效果综述
Raymond W Nims,Gay Gauvin,Mark Plavsic
Raymond W Nims
Animal-derived materials such as animal sera represent a low, but finite, risk for introduction of an adventitious agent (virus or mollicute) into a biological bulk harvest during upstream manufacturing processes involving mammalian cell su...
Current development in regulation of similar biotherapeutic products in Brazil [0.03%]
巴西相似生物制品监管的最新进展
Laura Gomes Castanheira,Dirceu Brás Aparecido Barbano,Norberto Rech
Laura Gomes Castanheira
Because of the recent expiry of a large number of patents on the originator biological products, interest in the production and marketing of similar biotherapeutic products in Brazil has been increasing. The national producers have signific...
An Indian manufacturer's perspective for harmonization of guidelines for similar biotherapeutic products [0.03%]
印度制造商的类似生物药指南协调的观点
P V Cherish Babu
P V Cherish Babu
This review focuses on the scenario of Indian manufacturers, biotherapeutics approvals in India and important aspects which need to be precisely analyzed and resolved from the Indian perspective to facilitate implementation of global guidel...