More Articles

China and India still to comply with new EU API rules Policies & Legislation | Posted 29/04/2013

The European Union (EU) has introduced new rules for importing active pharmaceutical ingredients (APIs) for human use into Europe; however, two of its biggest suppliers have yet to put systems in p...

Celltrion stops phase III trial of biosimilar rituximab Biosimilars/News | Posted 29/04/2013

South Korean biotechnology company Celltrion has stopped the late-stage trial of its biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

UK accuses GSK of delaying generics Pharma News | Posted 29/04/2013

The UK’s competition watchdog is accusing GlaxoSmithKline (GSK) of delaying the entry of generics to its antidepressant drug Seroxat (paroxetine) by paying rival companies to stay off the market.

More UK patients affected by drug shortages in 2012 Reports | Posted 29/04/2013

The number of UK patients affected by shortages in brand-name medicines has increased during 2012, according to an online survey carried out by pharmacists’ organization Chemist+Druggist (C+D).

Daiichi Sankyo and Ranbaxy announce synergy in Brazil Generics/News | Posted 29/04/2013

India-based Ranbaxy Laboratories (Ranbaxy) and its Japanese parent company Daiichi Sankyo announced on 17 April 2013 plans to integrate their generic and brand-name drug business operations in Brazil.

Generics applications under review by EMA – 2013 Q1 Generics/General | Posted 29/04/2013

Last update:  6 September 2013Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by...

Efficacy, extrapolation and interchangeability of biosimilars Biosimilars/Research | Posted 19/04/2013

Biosimilars have been available in Europe for more than seven years; despite this fact, physicians still have concerns about the use of biosimilars. Some of their concerns have been discussed by me...

FDA is dragging its feet over oxycodone generics Generics/General | Posted 19/04/2013

The US patent for Purdue Pharma’s (Purdue’s) blockbuster painkiller OxyContin (oxycodone) expired on 16 April 2013, but FDA has yet to approve any generic versions. Now, FDA has announced that it w...