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Amgen sues Sandoz over filgrastim biosimilar Biosimilars/News | Posted 14/11/2014

Biologicals major Amgen is suing Sandoz to stop the biosimilars maker from marketing a biosimilar of its top-selling product Neupogen (filgrastim) in the US. Amgen claims in its lawsuit that Sandoz...

Canada partially lifts import ban on Indian manufacturing sites Generics/General | Posted 14/11/2014

In an attempt to avert drug shortages, Canada’s federal department responsible for health, Health Canada, has partially lifted an import ban on products from three Indian manufacturing facilities t...

Biosimilars use in Europe varies widely Reports | Posted 14/11/2014

Use of biosimilars in Europe varies widely between countries and therapy areas, according to a report published by IMS Health in October 2014.

FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs Generics/News | Posted 14/11/2014

India-based generics maker Ranbaxy Laboratories (Ranbaxy) announced on 6 November 2014 that the company had been informed by the US Food and Drug Administration (FDA) of the agency’s decision to re...

Xbrane signs biosimilar optimization deal with Indian pharma firm Pharma News | Posted 14/11/2014

Swedish biotech company Xbrane Bioscience (Xbrane) has signed an agreement with a global Indian pharmaceutical company to assist them in developing an optimized production system for a specific bio...

Another old drug to see huge price increase in the US Policies & Legislation | Posted 14/11/2014

Catalyst Pharmaceuticals (Catalyst) is preparing to increase the price of Firdapse (3,4-diaminopyridine) for the rare disorder Lambert-Eaton Myasthenic Syndrome (LEMS). This comes despite the fact...

EMA issues revised version of overarching biosimilars guideline Guidelines | Posted 07/11/2014

On 29 October 2014, the European Medicines Agency (EMA) published the new version of its overarching biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biol...

Biosimilars: similar but not identical Biosimilars/Research | Posted 07/11/2014

One reason for distrust among physicians over using biosimilars in extrapolated* indications could be the fact that it is frequently cited that biosimilars are ‘similar but not identical’ compared...