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Australian approval for biosimilar insulin posted 26/05/2015

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has given a positive recommendation for the listing of Eli Lill...

Iran approves its first rituximab biogeneric posted 15/05/2015

In May 2015, Iran’s National Regulatory Authority, the Food and Drug Organization (FDO), approved its first rituximab biogene...

Venezuelan approval for Celltrion’s Remsima posted 11/05/2015

Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Vene...

Brazil approves first monoclonal antibody follow-on biological posted 04/05/2015

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), annou...

Samsung adds 48-week extension to SB4 biosimilar study posted 29/04/2015

Samsung Bioepis has added a 48-week extension to the phase III study of its candidate etanercept biosimilar SB4 in rheumatoid...

 

Research

Clinical trials for etanercept biosimilars posted 26/05/2015

Researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for...

Variation in biosimilar recombinant streptokinase posted 26/05/2015

A study of blood clot dissolving drug streptokinase has highlighted the mantra of ‘the process is the product’ in the case of...

Clinical trials for adalimumab biosimilars posted 26/05/2015

As part of their investigation into biosimilars for the treatment of psoriasis, researchers from the Charité – Universitätsme...

Biosimilar filgrastim highly similar to originator filgrastim posted 26/05/2015

A study comparing Sandoz’s filgrastim biosimilar (Zarzio) with originator filgrastim (Neupogen) has shown that they are highl...

Clinical trials of biosimilars for psoriasis treatment posted 26/05/2015

Tumour necrosis factor-alpha (TNF-alpha) is a cytokine, or protein, that prompts the body to create inflammation. In psoriasi...

 

General

Biosimilars approved in Australia posted 27/05/2015

Last update: 22 May 2015In Australia, the legal framework for approving medicines was established via the Therapeutic Go...

Biosimilars Forum launched posted 08/05/2015

A group of biosimilars developers in the US announced on 5 May 2015 the launch of a joint initiative to promote biosimilars i...

Australian guide to biosimilars posted 04/05/2015

Australia’s Generic Medicines Industry Association (GMiA) has launched a Guide to Biosimilars. The guide is designed to provi...

WHO receives positive feedback on BQ for biologicals posted 27/04/2015

According to the World Health Organization’s executive summary of its 59th Consultation on International Nonproprietary Names...

Generics group established first voice for biosimilars in Canada posted 27/04/2015

The Canadian Generic Pharmaceutical Association (CGPA), which represents Canada’s generics industry, announced on 7 April 201...

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