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Positive phase III results for omalizumab copy biological posted 27/05/2016

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had su...

Samsung Bioepis to launch infliximab biosimilar in South Korea posted 20/05/2016

Samsung Bioepis has completed the regulatory process to enable the launch of its second biosimilar Renflexis (infliximab) in...

Samsung Bioepis starts phase III trial for bevacizumab biosimilar posted 06/05/2016

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis has started a ph...

New administration route for epoetin alfa biosimilar Binocrit posted 22/04/2016

Sandoz, the generics division of Novartis, announced on 8 April 2016 that the European Commission (EC) has approved a type II...

BioOutsource launches ready-to-use biosimilarity assays posted 15/04/2016

Sartorius Stedim BioOutsource (BioOutsource), a subsidiary of Sartorius Stedim Biotech, has launched a range of ready-to-use...

 

Research

Switching between different ESAs posted 27/05/2016

Switching between reference biologicals and biosimilars can be a contentious issue. A study from Italy, however, has found th...

Uptake of biosimilars increasing in Spain posted 25/05/2016

Use of biosimilars in Madrid, Spain, has increased after approaches were introduced to try and improve uptake of biosimilars...

Clinical and regulatory issues for biosimilars posted 25/05/2016

As the first biosimilars are being approved in the US, there are a number of clinical and regulatory issues that must be cons...

Approaches to increase uptake of biosimilars in Spain posted 25/05/2016

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe approaches that have been int...

A strategic approach to increase uptake of biosimilars in Spain posted 25/05/2016

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe the strategic approach that h...

 

General

Japan proving to be a favourable market for biosimilars posted 24/05/2016

Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimila...

Benepali wins Danish tender for etanercept posted 24/05/2016

Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the prior...

Biosimilars approved in Europe posted 20/05/2016

Last update: 6 May 2016In the European Union (EU), a legal framework for approving biosimilars was established in 2003....

Biosimilars approved in the US posted 20/05/2016

Last update: 6 May 2016In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics...

Biosimilars applications under review by EMA – April 2016 posted 20/05/2016

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A leg...

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