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Patent cliff winners and losers Generics/Research | Posted 11/01/2013

During 2011 and 2012 a whole host of patents have expired on many blockbuster drugs. In fact it was estimated that in 2012 US$33 billion of sales would be lost due to the patent cliff [1].

EMA publishes draft guideline for biosimilar human insulin Guidelines | Posted 11/01/2013

EMA announced on 14 December 2012 that it had published a draft guideline revising its current guideline on the non-clinical and clinical development of biosimilar human insulin and insulin analogu...

Biosimilar monoclonal antibodies on the horizon in Europe Biosimilars/Research | Posted 11/01/2013

European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted the final guideline on biosimilar monoclonal antibody (mAb) and it came into effect in December 2012. The ag...

Significance of locally produced biosimilars in Iran Biosimilars/Research | Posted 11/01/2013

Biopharmaceuticals, drugs produced by live cell culture, have a fast growing market for the treatment of a range of conditions. Despite their clinical importance, however, their cost could impose a...

French Government pushing generics Generics/General | Posted 11/01/2013

The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, with rising healthcare costs and austerity measures hitting healthcare budgets, the Fren...

Biosimilars applications under review by EMA – 2012 Q4 Biosimilars/General | Posted 11/01/2013

Last update: 23 August 2013 European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 20...

Teva makes South Korean joint venture agreement Pharma News | Posted 11/01/2013

Teva Pharmaceutical Industries (Teva) announced on 16 December 2012 that it had made an agreement with Handok Pharmaceuticals (Handok) to establish a business venture in South Korea.

CCM and Biocon make biosimilar insulin deal Biosimilars/News | Posted 11/01/2013

Malaysia-based Chemical Company of Malaysia Berhad (CCM), announced on 14 December 2012 an agreement between its subsidiary, CCM Pharmaceuticals Sdn Bhd (CCMP), and India-based Biocon, giving CCMP...