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To ensure that clinicians buy into biosimilars, it is important that they understand how products are analysed and compared to the originator molecules. Dr Fraser Cummings and Jonathan Sweeting discussed this issue at a recent virtual roundtable event, where they highlighted the complexities of biosimilar development pathways and approval processes. Here, Nikki Withers shares the…
Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars.
18 July 2016 | By Victoria White, Digital Content Producer
At an estimated $4billion a year, the reference product, Humira, is among the European Union's largest single drug expenditures...
31 May 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade...
18 January 2016 | By Victoria White
Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there...
20 November 2015 | By Victoria White
Previously known as SB4, Benepali (etanercept) is a biosimilar candidate to the reference product Enbrel...
10 February 2014 | By Merck
Merck and Samsung Bioepis Co., Ltd., announced that they have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293...
17 December 2013 | By Biogen Idec
Biogen Idec opts-in to commercialization opportunity with joint venture partner...
27 February 2012 | By Biogen Idec
Samsung Biologics & Biogen Idec have established their joint venture...
