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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...

Production of 24 biogeneric products in Iran by 2012 Biosimilars/News | Posted 03/02/2012

According to reports on Iran’s English-language television network, Press TV, Iran is making significant advances in biogeneric products and biotechnology drugs and is planning to start the product...

Suppliers of products on the drug shortages list in the US Reports | Posted 03/02/2012

Although overall a large number of producers supply the drugs on the shortages list in the US, most of the drugs are supplied by only one or two companies according to a new report published by IMS...