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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...

FDA blocks Indian API supplier Generics/News | Posted 30/09/2011

In a bid to get tough on foreign manufacturers, FDA has issued a warning letter and a US import ban to an Indian-based active pharmaceutical ingredient (API) manufacturer.

EMA biosimilar regulation should include complex biologicals Biosimilars/Research | Posted 23/09/2011

The EMA’s comprehensive biosimilar regulatory pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, should be expanded t...

Debate over biosimilars exclusivity period in free trade agreement Generics/News | Posted 23/09/2011

With the eighth round of negotiations of the Trans-Pacific Partnership (TPP) agreement underway in Chicago, USA, on 12 September 2011 Democrat senators were split on the inclusion of intellectual p...

Generics and biosimilars affected by Obama’s deficit plans Biosimilars/News | Posted 23/09/2011

US President Barack Obama’s plan for economic growth and deficit reduction, announced on 19 September 2011, recommends a series of healthcare reforms. The proposals include higher drug rebates for...

US biosimilars law may prove a barrier to entry for biosimilars Biosimilars/Research | Posted 23/09/2011

One of the main barriers to biosimilar entry in the US is the US biosimilars law [1]. While some have questioned whether the biosimilars pathway in the US will ever be used [2, 3], others believe t...

China cuts drug prices for the second time in 2011 Policies & Legislation | Posted 23/09/2011

China has, for the second time this year, cut the price of drugs. The maximum retail price of 82 different pharmaceutical drug types has been lowered by an average 14% in a move to reduce patient’s...

The biosimilars landscape Biosimilars/Research | Posted 23/09/2011

There is obviously a market for biosimilars. This is driven by the cost savings to be made by payers and patients alike. By 2015, IMS Health (IMS) expects spending on biosimilars to exceed US$2 bil...