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Industry adjustments as patents expire Generics/General | Posted 14/10/2011

Analysts are making some positive predictions as they consider the implications of the continued patent expiry of many blockbuster originator drugs.

EMA plans to revise biosimilar guidelines Biosimilars/News | Posted 07/10/2011

EMA announced on 3 October 2011 that it has published a concept paper asking for comments on topics to be included in a potential revision of the agency’s 2006 biosimilar guideline, which covers no...

Biosimilar user fee levels and performance goals for the FDA Biosimilars/News | Posted 07/10/2011

FDA and representatives from the drug industry negotiating a user fee for biosimilars have tentatively set performance goals and biosimilar user fee levels, creating a separate review programme for...

Generics saved US$931 billion over last 10 years Generics/Research | Posted 07/10/2011

On 21 September 2011, the US Generic Pharmaceutical Association (GPhA) released the results of an independent analysis showing that the use of generic drugs in the US has saved patients and the hea...

How profitable will biosimilars be Biosimilars/Research | Posted 07/10/2011

The profitability of biosimilars remains an open question. Five years after launch it is thought that most biosimilars markets will look similar to generics markets (70% penetration, 25% of brand-n...

Pfizer and US pharmacies fight counterfeit medicines Pharma News | Posted 07/10/2011

Pfizer and the US National Association of Boards of Pharmacy (NABP) announced on 29 September 2011 that they have launched a new effort to draw attention to the risks associated with counterfeit dr...

FDA new drug approvals up in 2011: 900 biotech drugs in development Biosimilars/News | Posted 07/10/2011

FDA had already approved 26 new drugs by the end of August 2011 compared to only 21 approved in 2010. Of note were six cancer drugs and two ground-breaking drugs for hepatitis C. The current year l...

Teva takes over joint venture solidifying its position in Japan Generics/News | Posted 07/10/2011

Teva announced on 26 September 2011 that it will acquire the 50% interest formerly held by Kowa Company in Teva’s Japanese joint venture for US$150 million, giving it full control.