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Amgen welcomes biosimilar monoclonal antibody guideline Biosimilars/News | Posted 22/06/2012

In a statement issued on 18 June 2012, biologicals major Amgen announced that the company broadly supports the scientific principles behind the guideline on non-clinical and clinical aspects for bi...

Rise in US spending on generics: a buoyant market as patents expire on brand-name drugs Reports | Posted 22/06/2012

A new IMS report notes a rise in spending on generic medicines in the US to 27%, or US$75 billion, and looks at the main changes driving the trend.

China follows the Indian and Thai route to affordable drugs Generics/General | Posted 22/06/2012

China announced measures for the Compulsory Licensing for Patent Implementation in a statement on 1 May 2012. The country is saying that it intends to become a generics producer for the domestic an...

Risk management is forgotten as FDA reform struggles through Congress Policies & Legislation | Posted 22/06/2012

FDA’s authority on new drug approvals and post-marketing reports was last updated in 2007, when Congress passed the FDA Amendments Act (FDAAA), and this time the deadline is 30 September 2012 for t...

Trials of biosimilar monoclonal antibody prove biosimilarity Biosimilars/News | Posted 22/06/2012

South Korean biotechnology company Celltrion presented the PLANET clinical studies results of phase I and phase III trials for its first monoclonal antibody biosimilar (CT-P13) of Johnson & Joh...

Management of drugs shortages Generics/Research | Posted 22/06/2012

The number, range and duration of drug shortages in the US appear to be, at best, maintaining the levels seen in the recent past. It is now becoming essential for institutions to draft formal polic...

More capacity needed in clinical trial review for national approval of biosimilars Reports | Posted 22/06/2012

The need for National Regulatory Authorities to build capacity in clinical trials review, and for WHO to continue monitoring regulatory procedures for the evaluation of biosimilars were among the m...

WHO guidelines on biosimilars: case studies and discussion highlights Reports | Posted 18/06/2012

The experiences and progress of different countries in implementing WHO guidelines on evaluating biosimilars were the focus of a workshop hosted jointly by WHO and Korea Food and Drug Administratio...