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Volume and sales of drugs on the shortages list in the US Reports | Posted 10/02/2012

Despite record numbers of drug shortages being reported in the US [1], on the whole, over the past five years the supply of these drugs to healthcare providers–hospitals, clinics, pharmacies–has in...

Registration of biosimilars in Europe and the US Biosimilars/Research | Posted 10/02/2012

Europe is way ahead of the US in terms of biosimilars regulation. A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration proces...

Mexican guidelines for biocomparables Guidelines | Posted 10/02/2012

Last update:  25 May 2012The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The agency is a decentralised o...

Tentative FDA approval for generic HIV treatment Generics/News | Posted 10/02/2012

FDA announced on 31 January 2012 that it had given tentative approval for generic versions of GlaxoSmithKline’s (GSK’s) blockbuster AIDs treatment Epzicom (abacavir sulfate and lamivudine). The ten...

Spinnovation enters biosimilar collaboration with Quantum Tessera Biosimilars/News | Posted 10/02/2012

Dutch-based bioanalysis specialist Spinnovation Biologics (Spinnovation) announced on 24 January 2012 that it had entered into a collaboration with US-based consulting company Quantum Tessera.

Ranbaxy consent decree with FDA submitted to court Generics/News | Posted 10/02/2012

Ranbaxy Laboratories (Ranbaxy) announced on 26 January 2012 that the consent decree with FDA that was signed on 20 December 2011 has been filed with the United States District Court for the Distric...

Factors affecting market access of biosimilars Biosimilars/Research | Posted 03/02/2012

Growth in the use of biosimilars is being driven by the need to reduce healthcare costs, patent expiries on blockbuster originator biologicals and better-defined regulatory pathways.

Generic and biosimilar user fee recommendations sent to Congress Generics/News | Posted 03/02/2012

FDA has sent recommendations for user fee programmes, including those covering generic and biosimilar drugs, to US Congress. It is hoped that the fees will help speed up the delivery of safe and ef...