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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...

Cipla launches first etanercept ‘similar biologic’ in India Biosimilars/News | Posted 19/04/2013

India-based generics manufacturer Cipla announced on 17 April 2013 the launch of its ‘similar biologic’ product Etacept, the first ‘similar biologic’ of etanercept in India.

Patients in US turn to generics to save money Reports | Posted 19/04/2013

According to a new report released on 9 April 2013 by the US Centers for Disease Control and Prevention, adults in the US used several strategies to reduce the costs of their medications, including...

Indian high court allows sitagliptin generics Policies & Legislation | Posted 19/04/2013

In the latest development in Merck Sharp and Dohme’s (MSD’s) court case over the patent infringement of its diabetes drugs, an Indian high court has refused to grant interim relief to MSD, thus all...

Mylan gains approval for generic of Valeant’s Zovirax Generics/News | Posted 19/04/2013

Generics giant Mylan announced on 3 April 2013 that its subsidiary Mylan Pharmaceuticals had received final approval from FDA for its abbreviated new drug application (ANDA) for acyclovir ointment 5%.