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US FDA prepares for biosimilars in 2011 budget plan, despite stalled healthcare reform bill Biosimilars/News | Posted 03/03/2010

Increasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the US FDA's fiscal 2011 budget request, US Department of Health and H...

EGA wants better Centralised Procedure and Decentralised Procedure for generics authorisation Generics/General | Posted 03/03/2010

The European Generic medicines Association (EGA) presented ‘Vision 2015’, which aims to create a globally competitive generic industry, increase patient access to affordable quality medicines and e...

Bionomics of biosimilars - Indian options for investors Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have...

Bionomics of biosimilars – EU and US markets not easy for India Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have...

Bionomics of biosimilars – Indian opportunities Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have...

Bionomics of biosimilars – India’s next big cash cow? Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. According to her, however, players have many knots to untangle be...

FDA accepts Teva’s biosimilar filgrastim BLA, Amgen not Biosimilars/News | Posted 26/02/2010

The US FDA has accepted Teva‘s application to sell a biosimilar version of Amgen's Neupogen (filgrastim), although the biotech giant is working to block the move in court.XM02, a granulocyte colony...

Originator/generic competition: who's the 'bad guy'? Pharma News | Posted 26/02/2010

As reported in Scrip News on 28 January 2010 by Xavier Buffet Delmas and Laura Morelli of Hogan & Hartson MNP, Paris, intellectual property rights are key elements of the fierce competition bet...