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Australia reviewing plans for naming biosimilars Guidelines | Posted 23/01/2015

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has changed its plans for naming biosimilars, ‘following recent international developments in the area of biosimilar...

Biosimilar etanercept submitted for approval in EU Biosimilars/News | Posted 23/01/2015

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21 January 2015 that its etanercept biosimilar candidate, SB4, had been acc...

Generics applications under review by EMA – December 2014 Generics/General | Posted 23/01/2015

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...

Filgrastim biosimilar has similar safety and efficacy to Neupogen Biosimilars/Research | Posted 23/01/2015

A filgrastim biosimilar (EP2006) from Sandoz, the generics division of Swiss pharma giant Novartis, has shown similar safety and efficacy compared to Amgen’s Neupogen (filgrastim) in a pivotal phas...

Amgen’s approach in the biosimilars market Pharma News | Posted 23/01/2015

Biotech giant Amgen now has a biosimilars programme that includes nine different molecules [1]. A representative from Amgen has spoken to GaBI about the company’s venture into biosimilars [2].

Prasco to market authorized colchicine generic in the US Generics/News | Posted 23/01/2015

US generics maker, Prasco Laboratories (Prasco), announced on 12 January 2015 that it had entered into an alliance with the US subsidiary of Japanese pharmaceutical company, Takeda, to distribute a...

UK outlines process for developing biosimilars guidances Policies & Legislation | Posted 23/01/2015

In response to the increasing availability and use of biosimilars by the UK’s National Health Service (NHS), the country’s healthcare watchdog, the National Institute for Health and Care Excellence...

Mabion starts phase III trial for rituximab biosimilar Biosimilars/News | Posted 23/01/2015

Polish biologicals company Mabion announced on 25 November 2014 that it had received the consent of the appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to s...