Statistical considerations for confirmatory clinical trials for similar biotherapeutic products [0.03%]
相似生物制品确证性临床试验的统计学考虑因素
Catherine Njue
Catherine Njue
For the purpose of comparing the efficacy and safety of a Similar Biotherapeutic Product (SBP) to a Reference Biotherapeutic Product (RBP), the "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)" issued by the World Health ...
Chemical disinfection of high-consequence transboundary animal disease viruses on nonporous surfaces [0.03%]
高致病性动物传染病病毒光滑表面化学消毒效果研究
Peter W Krug,Laura J Lee,Angelique C Eslami et al.
Peter W Krug et al.
Disinfection is a critical part of the response to transboundary animal disease virus (TADV) outbreaks by inactivating viruses on fomites to help control infection. To model the inactivation of TADV on fomites, we tested selected chemicals ...
Arpah Abas
Arpah Abas
The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to th...
A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products [0.03%]
世卫组织《生物类似药评价指南》的实施——生物类似药行业的观点
Martin Schiestl
Martin Schiestl
The WHO guidelines on evaluating biosimilar products represent an important step forward in the global harmonization of biosimilar(1) products regulation, and provide clear guidance for regulatory bodies and industry. They confirm the key p...
Soo Kyung Suh,Younjoo Park
Soo Kyung Suh
The regulatory framework of biosimilar products in Korea is a 3-tiered system: 1) Pharmaceutical Affairs Act; 2) Notification of the regulation on review and authorization of biological products; 3) Guideline on evaluation of biosimilar pro...
Biosimilars and non-innovator biotherapeutics in India: an overview of the current situation [0.03%]
印度仿制生物药概览：现状分析
Hemant Malhotra
Hemant Malhotra
Globally, a large number of blockbuster biotherapeutic molecules are going off patent in the next few years. For emerging economies, like India, it is imperative to be able to provide safe and cost effective drugs for its huge, non-insured ...
Reviewing non clinical data for a granulocyte colony stimulatory factor product: experience in Brazil [0.03%]
巴西一种粒细胞集落刺激因子产品的非临床数据评审经验
Laura Gomes Castanheira
Laura Gomes Castanheira
Non clinical studies are one of the requirements for the Brazilian National Regulatory Authority, ANVISA, for licensing a similar biotherapeutic product. During the WHO/KFDA workshop on implementing WHO guidelines on evaluating similar biot...
The first subsequent entry biologic authorized for market in Canada: the story of Omnitrope, a recombinant human growth hormone [0.03%]
加拿大市场上首个获批的后续进入生物制剂——Omnitrope重组人生长激素上市始末
Agnes V Klein
Agnes V Klein
Omnitrope is the first Subsequent Entry Biologic (SEB)/Similar Biotherapeutic Product (SBP) filed with Health Canada, for purposes of marketing. Health Canada is the home organization of the Regulatory Authority in Canada. As the first SEB ...
Jalene Poh,Kai Tong Tam
Jalene Poh
The expiration of patents on many biological medicinal products has prompted the development of these products as similar biological (biosimilar) products. The standard approach of demonstration of bioequivalence for chemical generic produc...
C Brownie,J Statt,P Bauman et al.
C Brownie et al.
An important consideration in the manufacture of products derived from animal or human sources is the virus reduction capacity of the manufacturing process as estimated using validated bench-scale models of relevant manufacturing steps. In ...