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News

20893354_l Japan approves first darbepoetin alfa biosimilar posted 14/09/2018

Japan-based Kyowa Hakko Kirin announced on 16 August 2018 that it had gained Japanese approval for its darbepoetin alfa biosi...

Trastuzumab and Bevacizumab products approved in Australia and Argentina posted 07/09/2018

Australia has approved a trastuzumab biosimilar and Argentina has approved a bevacizumab medicamento biológico similar.

EMA approves adalimumab and pegfilgrastim biosimilars posted 03/09/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 July 2018 that it...

20893354_l FDA approves filgrastim biosimilar Nivestym posted 24/08/2018

On 20 July 2018, the US Food and Drug Administration (FDA) approved its second filgrastim biosimilar. The filgrastim biosimil...

Rituximab biosimilar submitted to EMA and Rituxan gains extra indication posted 20/07/2018

Poland-based Mabion announced on 1 June 2018 that its candidate rituximab biosimilar (MabionCD20) had been accepted for regul...

 

Research

Comparison of biosimilar and originator bevacizumab in NSCLC posted 14/09/2018

A study carried out by international researchers reported results from a comparative clinical study of PF‑06439535, a candida...

Pooled analysis results of adalimumab, etanercept and infliximab biosimilars posted 07/09/2018

South Korean electronics giant Samsung and biotechnology company Biogen Idec (Biogen) joint venture Samsung Bioepis, along wi...

Comparison of trial and real-world data for biosimilar filgrastim posted 07/09/2018

A study carried out by researchers from Germany compared results from a randomized controlled trial (RCT) of Sandoz’s biosimi...

Alternative mAb purification strategies: a tool to increase global access to biotherapeutics? posted 07/09/2018

The monoclonal antibodies’ (mAbs) market is dominant among therapeutic biologicals. Between 2013 and 2017, it has witnessed t...

Positive switching data for infliximab and etanercept biosimilars posted 07/09/2018

Sandoz, the generics division of Novartis, announced on 15 June 2018 results of new phase III, long-term and switching data f...

 

General

Extension of indications and manufacturing approval for biologicals in the US posted 14/09/2018

Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received a...

FDA guidance sought on false and misleading information on biosimilars posted 07/09/2018

Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor com...

Biosimilars approved in Australia posted 31/08/2018

Last update: 31 August 2018In Australia, the legal framework for approving medicines was established via the Therapeutic Good...

Biosimilars approved in the US posted 31/08/2018

Last update: 31 August 2018In the US, a legal framework for approving biosimilars was established in 2009, via the Biolo...

European nurses launch biosimilar switching guide posted 24/08/2018

The European Specialist Nurses Organisations (ESNO) announced on 26 June 2018 the launch of a guide for switching from refere...