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Remsima approved in Colombia Biosimilars/News | Posted 10/01/2014

On 16 December 2013, Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) announced the approval of Remsima (infliximab)...

Sandoz starts phase III biosimilar adalimumab trial Biosimilars/News | Posted 10/01/2014

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 18 December 2013 the start of a phase III clinical trial for a biosimilar version of adalimumab in patients suffering fr...

Generics applications under review by EMA – 2013 Q4 Generics/General | Posted 10/01/2014

Last update:  20 January 2014Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by E...

Phase III QoL assessments show comparability of biosimilar infliximab Biosimilars/Research | Posted 10/01/2014

The results of phase III quality of life (QoL) assessments of a candidate biosimilar infliximab (CT-P13) have shown the comparability of the biosimilar (CT-P13) and its reference product, Johnson &...

First generics of Cymbalta approved by FDA Generics/News | Posted 10/01/2014

The US Food and Drug Administration (FDA) announced on 11 December 2013 that it had approved the first generic versions of duloxetine delayed-release capsules, a prescription medicine used to treat...

Bioanalytical challenges in the development of biosimilars Biosimilars/Research | Posted 10/01/2014

Some of the topics presented at an international conference on biowaivers and biosimilars, held in the US in September 2012, were applicable to large-molecule bioanalytical methods. These included...

Recent reforms and initiatives in Scotland to encourage the prescribing of generic drugs and the implications Generics/Research | Posted 13/12/2013

Scotland has introduced a number of reforms and initiatives in recent years to enhance the prescribing of low cost generics, thereby saving money to help fund increased volumes and new premium pric...

Shortage of HIV/AIDS drugs in South Africa Reports | Posted 13/12/2013

According to a survey of South African clinics, one in five of them are running short of life-saving HIV/AIDS drugs, affecting nearly half a million people and undermining the success of the world’...