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Sandoz gains Danish approval for innovative asthma inhaler Generics/News | Posted 10/01/2014

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 18 December 2013 that it had received Danish marketing authorization for AirFluSal Forspiro, a novel inhaler for patients with...

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...