More Articles

China releases draft biosimilars guidance Guidelines | Posted 14/11/2014

On 29 October 2014 China’s Center for Drug Evaluation (CDE) published draft guidance for approval of biosimilars.

Biosimilars: when indications can be extrapolated Biosimilars/Research | Posted 14/11/2014

Extrapolation* is already a well-established and accepted scientific and regulatory principle, according to members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Pa...

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...