The rise of biosimilars – navigating regulatory complexity in Europe
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.
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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...