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FDA approves generics of Merck’s Singulair Generics/News | Posted 10/08/2012

FDA announced on 3 August 2012 that the agency had approved not one, but ten generic versions of Merck’s blockbuster asthma-allergy drug Singulair (montelukast).

iBio and GE Healthcare form new global alliance Biosimilars/News | Posted 10/08/2012

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, and GE Healthcare, the health business of General Electric, announced on 26 July 2012 a new global alliance...

FDA urged to exclude plasma protein therapies from biosimilar pathway Biosimilars/General | Posted 03/08/2012

FDA is being lobbied by patient and industry groups to exclude plasma protein therapies from its pathway for the approval of biosimilars. FDA has a mandate to create a new abbreviated process for t...

Australia moves towards pricing policy for biosimilars Policies & Legislation | Posted 03/08/2012

The Australian Pharmaceuticals Industry Council (PIC) has agreed to a broad strategy for the pricing of biosimilars so as to encourage the development and entry of biosimilars into the market place.

Deal struck over development of Herceptin biosimilar Biosimilars/News | Posted 03/08/2012

Netherlands-based biopharmaceutical company Synthon announced on 18 July 2012 that it has entered into a global licensing agreement with Amgen and Watson Pharmaceuticals for the clinical developmen...

Global uptake of biosimilars Reports | Posted 03/08/2012

About 85% of the human world population lives in an emerging economy, where biosimilars are less-regulated or even unregulated. Taking into account the huge cost of originator biologicals, and with...

Positive results from phase I study with biosimilar insulin glargine Biosimilars/Research | Posted 03/08/2012

Leading biotech company Biocon announced on 25 July 2012 positive results from a phase I comparative study conducted in Germany of its biosimilar insulin glargine in type 1 diabetes mellitus (...

Pfizer wins against generic versions of pain drug Lyrica Generics/News | Posted 03/08/2012

The world’s largest drugmaker Pfizer has successfully blocked Israel-based Teva Pharmaceutical Industries (Teva) and other manufacturers from selling generic versions of its fibromyalgia treatment...