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Quality attribute changes for rituximab Biosimilars/Research | Posted 20/05/2011

Last updated: 4 April 2013 Sandoz researchers found quality changes in commercially available rituximab (Rituxan/Mabthera) over a period of time. Since the drug remained on the market with an...

Questions over US biosimilars pathway in light of Teva’s BLA Biosimilars/General | Posted 20/05/2011

Questions have arisen over whether the abbreviated pathway for approval of biosimilars in the US will ever be used. Many believe that biosimilars manufacturers will opt out of this pathway and use...

TNF copy biological approved in China Biosimilars/News | Posted 20/05/2011

China-based Simcere Pharmaceutical Group (Simcere) announced on 9 May 2011 that Shanghai Celgen Bio-Pharmaceutical (Shanghai Celgen) has received approval for Qiangke – a copy biological version of...

Europe’s industry concerned about converging prices and patient access Generics/General | Posted 20/05/2011

In response to a report on reference pricing in the EU, the European Federation of the Pharmaceutical Industries and Associations (EFPIA) says that while ‘it is rational for a Member State without...

Generic substitution generates savings in South Africa Generics/Research | Posted 20/05/2011

Savings of 9.3% over the 3-year study period could have been made with generic substitution of antidepressants according to research carried out by the School of Pharmacy at the North-West Universi...

Teva finally gets troubled Irvine plant back in action Pharma News | Posted 20/05/2011

Teva told the Wall Street Journal, on 3 May 2011 that its injectables facility in the US, which was shut down a year ago after quality control problems, has now received the green light from the FD...

Mylan’s attempt to stop Ranbaxy’s Lipitor exclusivity fails Generics/News | Posted 20/05/2011

On 2 May 2011 a federal judge dismissed Mylan’s attempt to block rival generic company Ranbaxy Laboratories from launching a generic version of Pfizer’s blockbuster cholesterol-lowering drug Lipito...

Comparability for biosimilar development Biosimilars/Research | Posted 13/05/2011

How does ‘comparability’ apply to biosimilar drug development? This was the question discussed by Dr Mark McCamish and Dr Gillian Woollett [1].