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India urged to drop cost-based drug policy Generics/General | Posted 30/11/2012

Indian industry trade group the Associated Chambers of Commerce and Industry of India (ASSOCHAM) has urged the Indian Government to drop its cost-based price controls on both brand-name and generic...

Overview of research on US regulatory issues surrounding biosimilars in 2012 Biosimilars/Research | Posted 30/11/2012

Period: January to August 2012 The US is somewhat behind Europe in the biosimilars race, but has issued draft guidance and is expected to have a practical biosimilar approval pathway in place...

Ranbaxy recalls generic atorvastatin in US Generics/News | Posted 30/11/2012

Ranbaxy Pharmaceuticals (Ranbaxy) has fallen foul of FDA once again. The Indian generics major announced on its US website that it is conducting a voluntary recall for certain batches of its atorva...

Competing biosimilars to Amgen’s biologicals Biosimilars/General | Posted 30/11/2012

Amgen has been a leading biotechnology company since 1980. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnolog...

Biosimilar policies in the UK Reports | Posted 30/11/2012

The UK was placed in 10th position in the global pharmaceutical markets in 2011 [1]. The UK also had some of the lowest prices for medicines in Europe [2]. Cost pressures and a well-developed gener...

History and future of pay-for-delay Generics/Research | Posted 23/11/2012

Pay-for-delay is a constant issue in both the US and Europe. But how did these settlements first come about and how have US courts attitudes towards such deals affected the pharmaceutical market [1].

China to release biosimilars guidelines Guidelines | Posted 23/11/2012

China, one of the largest pharmaceutical markets in the world, is ready to issue biosimilars guidelines.

FDA to tighten control over generics Policies & Legislation | Posted 23/11/2012

A single incident of an extended-release formulation that released its drug too quickly has caused FDA to change its policy. An FDA official said in October 2012 that the agency would be looking mo...