Biosimilars
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.
Interchangeability (switching and alternating) of biosimilars
The Biologics Price Competition and Innovation (BPCI) Act of 2009 established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars in the US. This act also established the principles of interchangeability (along with switching and alternating) with the reference product. However, the concept of biosimilarity and interchangeability for biosimilars is very different from that of bioequivalence and drug interchangeability for generics [1].
Indian Transgene sells biosimilar to German TSS Export
India-based biotech company Transgene Biotek Limited (Transgene) announced on 24 November 2011 the sale of technology for biosimilar recombinant human erythropoietin (rh-EPO) to TSS Export GmbH FZE, part of the Germany-based TSS group, for US$5 million (Indian Rupees 260 million).
National Psoriasis Foundation declares biosimilar stance
One of the leading psoriasis patient associations in the US, the National Psoriasis Foundation, has publically declared its stance on biosimilars. In an open letter to FDA, the Foundation issued a statement on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009 [1].
Quantitative evaluation of bioequivalence
Generics
For approval of small molecule generics, FDA requires that evidence of average bioequivalence in drug absorption in terms of pharmacokinetic (PK) parameters be provided through the conduct of bioequivalence studies. This may be done using the area under the blood and/or plasma concentration-time curve and peak concentration (Cmax) [1].
