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Maximising the potential of generics in Abu Dhabi Generics/Research | Posted 14/09/2012

IntroductionAll residents in Abu Dhabi have access to health care via mandatory health insurance. Nationals, who comprise 20% of the population with two-thirds under 30 years of age and half under...

Dr Reddy’s plans EU launch for biosimilar rituximab Biosimilars/News | Posted 14/09/2012

India-based generics drugmaker Dr Reddy’s Laboratories (Dr Reddy’s) is planning to launch its biosimilar monoclonal antibody Reditux (rituximab) in Europe.

Generics market set to increase in Japan Pharma News | Posted 14/09/2012

Japan has not been an easy place for drugmakers to do business. However, with government initiatives being introduced to increase generics use and taking into account the fact that Japan is current...

India’s patent laws coming under repeated challenges Policies & Legislation | Posted 14/09/2012

India’s patent laws are being challenged by Big Pharma. Novartis is challenging India for denying the pharma giant a patent for Glivec (imatinib mesylate), its blockbuster cancer drug. While Bayer...

Mylan generics launches in the US Generics/News | Posted 14/09/2012

Mylan has 166 abbreviated new drug applications (ANDAs) pending Food and Drug Administration approval representing US$78.4 (Euros 61.3) billion in annual sales. Thirty-five of these are potential f...

Poor quality pharma ingredients abound in China Generics/General | Posted 14/09/2012

Lack of regulatory enforcement in China is allowing poor quality pharmaceutical ingredients to be sold to drug manufacturers with potentially dangerous or even fatal consequences for patients.

Impax settles patent dispute with Genzyme Generics/News | Posted 14/09/2012

Impax Laboratories (Impax) announced on 4 September 2012 that it had reached an agreement with Sanofi subsidiary, Genzyme Corporation (Genzyme), to settle pending US litigation with regard to the p...

EMA responds to questions over biosimilar comparability Biosimilars/Research | Posted 07/09/2012

EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that demonstrate qua...