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US$54 billion worth of biosimilar patents expiring before 2020 Biosimilars/Research | Posted 30/09/2011

By 2020 biological products with sales of around US$23 billion in the EU and US$29 billion in the US are expected to be exposed to biosimilar competition [1].

Boehringer Ingelheim joins other Big Pharma going into biosimilars Biosimilars/News | Posted 30/09/2011

Big Pharma is once again taking a major interest in biosimilars. The latest big pharmaceutical player to show an interest is biopharmaceutical specialist Boehringer Ingelheim. The German-based comp...

Practical guidance on new pharmacovigilance legislation Policies & Legislation | Posted 30/09/2011

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is the regulatory body responsible for implementing much of the new legislation a...

Authorised generics implicated in pay-to-delay deals Pharma News | Posted 30/09/2011

A US Federal Trade Commission (FTC) report has found that authorised generics may reduce generics competition. The report also shows that some originator companies may have used agreements not to l...

Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit Biosimilars/News | Posted 30/09/2011

On 19 September 2011, and after years of conflict with FDA, Amphastar Pharmaceuticals (Amphastar) finally received approval to market a biosimilar version of sanofi-aventis’s blockbuster blood-thin...

Australia and New Zealand outline plans for joint regulatory agency Policies & Legislation | Posted 30/09/2011

The Australian and New Zealand governments have agreed to proceed with a joint scheme for regulation of therapeutic goods, i.e. medicines, medical devices, etc. The creation of a joint regulatory s...

Japanese government promoting generics Generics/News | Posted 30/09/2011

Japan is currently the world’s second largest pharmaceutical market, surpassed only by the US. The Japanese prescription drug market was valued at US$96 billion in 2010, however, only around 23% of...

Generic atorvastatin may be better than Crestor Generics/Research | Posted 30/09/2011

AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin) failed to show a statistically significant benefit over Pfizer’s Lipitor (atorvastatin), according to results of a phase IIIb trial. Th...