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Biosimilars

News

Adalimumab and trastuzumab biosimilars gain EC approval posted 21/09/2018

A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commissi...

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...

 

Research

Selection of quality attributes and test methods in biosimilarity assessment posted 21/09/2018

Biosimilar development starts with a detailed characterization of the quality profile of the chosen reference product, to est...

Increase in use of biosimilar rituximab for NHL treatment posted 21/09/2018

Researchers from the UK and US reported on how the treatment approach for non-Hodgkin lymphoma (NHL) patients has changed sin...

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...

 

General

Improving understanding of biotherapeutics and biosimilars posted 21/09/2018

Additional information on biosimilars and biotherapeutics have been published in Europe.

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...