More Articles

Generics manufacturers do not have to change drug safety labels in the US Generics/News | Posted 26/08/2011

A landmark ruling from the US Supreme Court has decided that generic drug manufacturers do not have to change their drug’s safety label, even if stronger safety warnings are found to be required [1...

China’s 5-year biotech investment fires clear warning to US Biosimilars/News | Posted 26/08/2011

The Chinese Government has targeted biotechnology as a ‘strategic pillar’ industry, and has pledged to spend 2 trillion yuan (Euros 213. 3 billion; US$308.5 billion) on science and technology in th...

Is FDA requesting too much data to allow biosimilars to succeed in the US Biosimilars/News | Posted 26/08/2011

The FDA’s recently published plans for a biosimilar approval pathway are facing increasing scrutiny. In an interview with Scientific American, Novel Health Strategies’ biosimilar market entry advis...

Integrated prescriber dispensing can slow generic growth Generics/Research | Posted 26/08/2011

Countries such as China, Japan and Taiwan which have public health insurance systems, and which allow physicians to both prescribe and dispense drugs themselves, are the most resistant to generics...

Does switching to generic anti-epileptic drugs lead to loss of seizure control Generics/Research | Posted 26/08/2011

Patients with epilepsy may have a higher risk of seizures if they switch from their brand-name medication to generic anti-epileptic drugs (AEDs). This is the message often heard from clinicians whe...

Pfizer seeks 6-month paediatric exclusivity for Lipitor Generics/News | Posted 26/08/2011

Pfizer is poised for a Lipitor (atorvastatin) reprieve in Europe. The company has asked for six months of additional exclusivity in most EU countries under regulations designed to promote drug tria...

FDA and biosimilars: process update Biosimilars/General | Posted 19/08/2011

Despite the fact that a legal pathway for the approval of biosimilars in the US has existed for more than a year, formal guidance has still not been issued by FDA. This has led many to question whe...

Pilot programmes between EMA, FDA and TGA a success Generics/General | Posted 19/08/2011

Two pilot programmes of collaboration on inspections between EMA, FDA and the Australian Therapeutic Goods Administration (TGA) have concluded successfully, according to two reports published by th...