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Generics

News

Sun Pharma adds generic tamsulosin and rivastigmine to portfolio posted 13/08/2010

Sun Pharma is gathering speed with a barrage of generic versions recently coming onto the market and with an extensive pipel...

Sun and Teva losing battle over generic Protonix posted 13/08/2010

On 19 July 2010, it was announced that a US court had denied a motion by India’s Sun Pharmaceutical Industries and Israel-ba...

New EGA chair to study generic medicines policies posted 13/08/2010

On 8 July 2010, Professor Steven Simoens was inaugurated as the new European Generic medicines Association (EGA) chair for ‘...

Court upholds decision against AstraZeneca’s omeprazole posted 10/08/2010

On 1 July 2010, the European Court of Justice (ECJ) upheld the decision of the European Commission (EC), which found that As...

Generics lose battle against AstraZeneca’s Crestor (rosuvastatin) posted 30/07/2010

On 30 June 2010, AstraZeneca announced that a court in the US had overruled challenges, from a number of generic producers,...

 

Research

International trends in generics: the EU posted 30/08/2010

Few studies have conducted an international price comparison of generic medicines as it is hard to access comparable data. A...

Bioequivalence testing for generics posted 09/07/2010

Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of most gen...

Are generic medicines in Europe too expensive? posted 21/06/2010

by Professor Steven Simoens, Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven,...

Teva CEO about opportunities in generics and biosimilars posted 15/03/2010

To retain its position in the long run, Teva Pharmaceutical Industries Ltd. aims at significant growth in the generic market...

Indian firms seek a higher profile in biosimilars posted 12/02/2010

As reported by Anju Ghangurde in Scrip News of 13 January 2010, large Indian companies appear to be keen to develop their ca...

 

General

FDA creates new division to speed up generic approval times posted 25/06/2010

As the FDA’s Office of Generic Drugs (OGD) struggles to keep up with its growing backlog of abbreviated new drug approvals (...

Generic substitution of cyclosporin sometimes undesired posted 26/03/2010

The bio-equivalence criteria of the Dutch Medicines Evaluation Board (CBG-MEB) offer insufficient guarantee for a safe subst...

India claims to be world leader in generics exports posted 17/03/2010

The Indian government has said that India ranks top in the world in exporting generic medicines, with a worth of 50,000 bill...

EGA wants better Centralised Procedure and Decentralised Procedure for generics authorisation posted 03/03/2010

The European Generic medicines Association (EGA) presented ‘Vision 2015’, which aims to create a globally competitive generi...

Should Indian generic firms partner with Big Pharma? posted 20/01/2010

After years of warding off generics, large pharmaceutical companies are embracing generic drug manufacturers and vying for a...