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Samsung Bioepis starts phase III trial for bevacizumab biosimilar posted 03/05/2016

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...

FDA approves infliximab biosimilar Inflectra posted 11/04/2016

The US Food and Drug Administration (FDA) announced on 5 April 2016 that it had approved the country’s second biosimilar Infl...

EMA recommends approval of infliximab biosimilar Flixabi posted 08/04/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 April 2016 that it...

 

Research

Improving uptake of biosimilars in Spain posted 03/05/2016

Author Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, investigated how efforts to imp...

Biosimilars: the clinical perspective posted 27/04/2016

How biosimilars can be viewed from a clinical perspective was discussed in a review of biosimilars in rheumatology by author...

A multidisciplinary perspective on biosimilars posted 19/04/2016

A biosimilar is an officially regulated and approved copy of an originator biological therapy. Authors Khraishi et al. aimed...

Biosimilars: management of clinical issues posted 19/04/2016

How to manage clinical issues encountered with biosimilars was a topic discussed in a review of biosimilars in rheumatology b...

European regulatory pathways for biosimilars posted 11/04/2016

The European regulatory pathways for biosimilars were discussed in a review of biosimilars in rheumatology by author José M S...

 

General

Biosimilars group launched in UK to improve biosimilars uptake posted 03/05/2016

On 18 April 2016, the British Generic Manufacturers Association (BGMA) announced the launch of its expert sector group on bio...

US rheumatologists in favour of distinct names for biosimilars posted 27/04/2016

Following the approval of the infliximab biosimilar Inflectra (infliximab-dyyb) the American College of Rheumatology (ACR) ha...

Biosimilars approved in Japan posted 27/04/2016

Last update: 22 April 2016In Japan, the regulatory body for the approval of medicines, including biologicals, is the Min...

‘Similar biologics’ approved and marketed in India posted 27/04/2016

Last update: 22 April 2016There have been established guidelines for approving generic versions of small molecule chemic...

Biosimilars of ranibizumab posted 22/04/2016

Last update: 15 April 2016Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevaci...

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