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Regulatory recommendations for biosimilars in the EU Guidelines | Posted 30/07/2010

The regulatory body for approval of medicines in the EU is the EMA. The EU has developed a general legal pathway, and the EMA has developed regulatory guidelines, for the approval of biosimilars (s...

The biosimilars challenge Biosimilars/Research | Posted 30/07/2010

What are the challenges facing biosimilars? This was the question broached in a paper by Professor Håkan Mellstedt of the Department of Oncology, at the Karolinska University Hospital Solna, Stockh...

MSD-Chibret signs generics deal with French manufacturer Reports | Posted 30/07/2010

On 25 June 2010 Merck Sharp & Dohme-Chibret (MSD-Chibret) signed an agreement with subcontractor Fareva under an incentive set up by the strategic council of health industries (Csis) meeting, a...

Italy to scrap tender system to boost generic volumes Reports | Posted 30/07/2010

On 23 June 2010, the Italian Health Minister, Mr Ferruccio Fazio, announced that Italy has decided to scrap its plans to introduce a new tendering system for reimbursable off-patent medicines in fa...

Opportunities for generic inhalation and nasal spray drugs Reports | Posted 30/07/2010

A new report from Espicom’s Senior Market Analyst, Mrs Karen Holmes, discusses emerging opportunities for inhalation and nasal spray drugs. It reviews currently available generic products and asses...

Ranbaxy launches generic atorvastatin in South Africa Generics/News | Posted 30/07/2010

Sales of Pfizer’s Lipitor (atorvastatin), the world's biggest-selling drug, are expected to take another blow as Ranbaxy South Africa (Ranbaxy SA) announced the launch of a generic version of atorv...

Approval of ‘hybrid generic’ PecFent (fentanyl) in EU Generics/News | Posted 09/07/2010

On 25 June 2010, Archimedes Pharma (Archimedes) announced that it had received a positive opinion from the CHMP of the EMA for its ‘hybrid generic’ PecFent (fentanyl).

Teva changes generic Yaz contraceptive label Generics/News | Posted 09/07/2010

Israeli generic giant Teva Pharmaceuticals has agreed to change the labelling on its generic oral contraceptive, Gianvi, after Bayer Schering Pharma (Bayer) filed a lawsuit accusing the company of...