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Sun comes under fire from Pfizer Generics/News | Posted 24/02/2012

Sun Pharmaceutical Industries (Sun Pharma) is coming under fire from Pfizer, as the generics major is sued for violating patents on Pfizer’s Protonix (pantoprazole).

WHO definitions of generics Generics/General | Posted 24/02/2012

Confusion often surrounds terms used in the global field of generics and biosimilars.

Score lines won’t delay generics Pharma News | Posted 24/02/2012

In an attempt to delay generics competition, Irish pharma company Warner Chilcott had added a second line or score to its Doryx (doxycycline hyclate) tablet. On 8 February 2012, FDA however denied...

Regulation of biosimilars in the US Biosimilars/News | Posted 24/02/2012

The US pharmaceutical industry plays a vital role in shaping the face of American health care. With major patent expiries and thin product pipelines, the industry is now considering new directions...

FDA finally issues draft biosimilar guidance Guidelines | Posted 17/02/2012

The long-awaited guidance for biosimilars in the US has finally arrived. FDA announced on 10 February 2012 that it had issued three draft guidance documents on biosimilar product development to ass...

Biosimilars: demonstrating ‘similarity’ Biosimilars/Research | Posted 17/02/2012

Most biological drugs are mixtures of closely related compounds, some of which are probably more active than others. Today, the state-of-the-art manufacturing struggles to deliver material that is...

Interchangeability not covered in FDA draft biosimilar guidance Guidelines | Posted 17/02/2012

FDA has finally issued draft guidance documents for biosimilars. However, the guidelines still do not address the issue of interchangeability of originator drugs and biosimilars.

Early warning system for drug shortages in the US Reports | Posted 17/02/2012

In response to the record high numbers of drug shortages in the US [1] the IMS Institute for Healthcare Informatics (IMS Institute) has published a list of recommendations consisting of an ‘early w...