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Development of biosimilars is not an easy matter Biosimilars/Research | Posted 28/10/2011

By 2020 biological products with sales of around US$23 billion in the EU and US$29 billion in the US will be exposed to biosimilar competition [1]. As more and more biologicals lose their patent pr...

Row continues over drug shortages Generics/General | Posted 28/10/2011

Unhappiness about persistent drug shortages is becoming more acute, both in Europe and the US. Hospitals in The Netherlands are routinely short of around 40 products, whereas in the US 180 medicati...

New stability testing rules for generics Policies & Legislation | Posted 28/10/2011

Both EMA and FDA are increasing their requirements for stability testing, especially for generic drugs. These changes could significantly increase the length of time required to gain regulatory app...

Access to generic medicines undermined in free trade agreement Generics/News | Posted 28/10/2011

On 19 October 2011, several leading Congressional Democrats wrote a letter to the US Trade Representative urging him to ensure that access to generic medicines in the developing world is not underm...

European Commission investigates Johnson & Johnson and Novartis over delaying generics Generics/General | Posted 28/10/2011

As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & Johnson (J&J) and Novartis to...

Injectable generics at Strides Arcolab Generics/News | Posted 28/10/2011

India-based drug firm Strides Arcolab announced on 3 October 2011 that it had received FDA approval to market injectable clindamycin, used in the treatment of bacterial infections, in the American...

Drawing score lines on pills to delay generics Pharma News | Posted 28/10/2011

Brand-name drugmakers have come up with numerous ways in the past to delay generics from entering the market. These can include making slight changes to the doses, introducing a paediatric form, pa...

Pfizer invests Euros 145 million in Irish biotech site Pharma News | Posted 28/10/2011

Pfizer, the world’s leading pharmaceutical company, is to make a substantial investment of Euros 145 million at its Grange Castle biotechnology manufacturing facility in Clondalkin, Dublin, Ireland...