Biosimilars
Baxter and Momenta make biosimilars deal
Baxter International (Baxter) and Momenta Pharmaceuticals (Momenta) announced on 22 December 2011 that they had entered into a global collaboration agreement to develop and commercialise biosimilars.
Top developments in biosimilars during 2011
Over the past year, a lot has happened in the biosimilars industry.
Amgen finally jumps on biosimilars bandwagon
Biotech giant Amgen and US generics manufacturer Watson Pharmaceuticals (Watson) announced on 19 December 2011 that the two companies had agreed to collaborate on the development and commercialisation of several cancer antibody biosimilars.
Hospira starts phase III programme for biosimilar erythropoietin
Hospira, self-proclaimed leader in injectable generics, announced on 9 January 2012 that the company had enrolled the first patient in its phase III programme in the US for its biosimilar erythropoietin (EPO).
India at the biotech crossroads
‘Indian biotech is at a crossroads. It must not only address the significant health needs of its domestic population, but also position itself to take advantage of the often more profitable global marketplace.’ [1]
First biosimilar G-CSF in Japan
Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 26 December 2011 that they had filed respective applications for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.
The cost-effectiveness of biosimilars
The biotechnology market is growing rapidly, driven by the imminent patent expiry of several major biologicals and enabled by the establishment of regulatory frameworks. The key driver for the biosimilars market is likely to be cost containment pressures in healthcare systems in the context of aging populations and of the current financial and economic crisis [1]. Because the medicines involved are so expensive, even a modest price reduction in percentage terms generates savings in the billions of euros over the EU as a whole [2].
Samsung makes biosimilars deal with Biogen Idec
Korean electronics giant Samsung announced on 6 December 2011 that it had entered into a biosimilars joint venture with US biotechnology company Biogen Idec (Biogen).
FDA biosimilar user fees meeting
FDA announced a public meeting to be held on 16 December 2011 to discuss its recommendations for the agency’s biosimilars user fee programme for 2013–17.
Health Canada definitions of generics and biosimilars
Attention has been brought to the fact that there is confusion surrounding terms used in the global field of generics and biosimilars. Some of this confusion has been attributed to authorities in various regions of the world defining terms differently and other instances are due to a misunderstanding of the actual nature, characteristics, and method of research and manufacture of these biological products.
