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Bioequivalence of generic cyclosporine Generics/Research | Posted 29/04/2011

A clinical trial in allogeneic stem cell transplant (ASCT) recipients found that generic and branded cyclosporine could be considered interchangeable.

FDA rejects pseudoephedrine application due to deficiencies Generics/News | Posted 29/04/2011

On 11 March 2011 SCOLR Pharmaceuticals announced it had received a letter from the FDA identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for its generic extended-releas...

Survey on rational use of medicines in 27 EU Members States Reports | Posted 22/04/2011

Measures for promoting the rational use of medicines in the 27 EU Member States were surveyed in a report by the Gesundheit Österreich GmbH / Österreichisches Bundesinstitut für Gesundheitswesen (G...

Pharmacodynamic response of biosimilar filgrastim Biosimilars/Research | Posted 22/04/2011

Research published online on 10 March 2011 on the pharmacodynamic response of recombinant human granulocyte colony-stimulating factor (G-CSF) filgrastim has shown that there is no difference betwee...

2011’s biggest patent expiries Policies & Legislation | Posted 22/04/2011

2011 looks set to be a bumper year for generics, with patents from some of the biggest selling drugs set to expire.

The history of the US biosimilar regulatory pathway Biosimilars/General | Posted 22/04/2011

The US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation Act [BPCI Act], which was signed into law on 23 March 2010 by President Barack Obama...

Still no word from FDA on generic user fees Policies & Legislation | Posted 22/04/2011

Well the FDA finally held its long-awaited meeting on generic user fees on 23 February 2011. However, since then there has been no news from the FDA as to when and how these user fees will be imple...

Immunogenicity of biosimilar low molecular weight heparins Biosimilars/Research | Posted 22/04/2011

In a presentation by Professor JM Walenga and colleagues from the Loyola University Medical Center, Illinois,USA, 'immunogenicity issues faced by biosimilar low molecular weight heparins (LMWHs)' w...