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Extrapolation for biosimilars Biosimilars/Research | Posted 24/10/2014

Regarding extrapolation* of indications for biosimilars, the European Medicines Agency (EMA) has stated that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy and...

Biosimilar bevacizumab similar to Avastin in preclinical assessments Biosimilars/Research | Posted 24/10/2014

Preclinical assessments have demonstrated the similarity of biologicals major Amgen’s biosimilar bevacizumab candidate (ABP 215) to Avastin [1].

Changes to pharmaceutical policy during an economic recession Generics/Research | Posted 24/10/2014

The use of antipsychotic medicines across Finland and Portugal following the recent economic recession have been analysed in order to gauge the impact of contrasting pharmaceutical policy intervent...

Norwegian study may be slowing adoption of biosimilar infliximab Biosimilars/News | Posted 24/10/2014

Norway is funding clinical studies in which patients will be switched from originator biological drugs to biosimilars [1]. However, some have speculated that the NOR-SWITCH study is actually slowin...

FDA names and shames firms for failing to pay generics fees Generics/General | Posted 24/10/2014

No less than 28 generics makers are currently on the US Food and Drug Administration’s (FDA) GDUFA (Generic Drug User Fee Amendments) Facility Arrears List for failing to pay generics fees for 2013...

Generics firms carve their way to victory Generics/News | Posted 24/10/2014

US generics company Mylan has won a court battle over brand-name drugmaker Hospira, meaning it is now free to resume distribution of generic Precedex (dexmedetomidine injection).

India drops planned price caps on non-essential drugs Policies & Legislation | Posted 24/10/2014

The Indian Government has scrapped plans to extend price cuts on both generic and brand-name drugs to include ‘non-essential’ drugs.

Generics save US 1.5 trillion over last 10 years Reports | Posted 24/10/2014

Generics have saved consumers and the US healthcare system US$239 billion in 2013 and have saved the US nearly US$1.5 trillion between 2004 and 2013, according to a report by the Generic Pharmaceut...