Biosimilars/Research
US approvals of biologicals doubled in last decade
Regulatory approvals for new biological drugs in the US have nearly doubled in the last decade compared with the 1990s, according to the May/June 2011 issue of the Tufts Center for the Study of Drug Development (CSDD) Impact Report. However, the author of the report, Research Assistant Professor Janice Reichert, said there are still ‘substantial challenges’ to be faced by biologicals manufacturers if they wish to ‘maintain that pace’.
Need for a global pathway for biosimilars
The need for access to biosimilars is global, yet the regulations are national. Issues with this approach are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].
Worldwide biosimilar development
The limited access to high-quality biologicals due to the cost of treatment constitutes an unmet medical need in the US and other regions of the world [1].
Opportunities for biosimilar development
Rising drug costs and limited healthcare budgets across the world, coupled with the fact that many biotechnology drugs will soon lose their patent protection, means that there is a huge opportunity for biosimilar manufacturers.
Comparability for biosimilar development
How does ‘comparability’ apply to biosimilar drug development? This was the question discussed by Dr Mark McCamish and Dr Gillian Woollett [1].
Regulatory approach to biosimilar development
Legislation in Europe in 2004 created a legal pathway for approval of biosimilars and the first biosimilar, Omnitrope (somatropin) as approved by the EMA in 2006. The US is lagging behind somewhat, having only just approved a legal pathway in March 2010 and with practical guidance from the FDA still anticipated.
Interchangeability or substitution of biosimilars
The interchangeability or substitution of biosimilars is a subject that differs somewhat between Europe and the US. These different approaches to biosimilars are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].
Changes in the quality attributes of darbepoetin alfa
Quality changes over a period of time were found in commercially available darbepoetin alfa (Aranesp) by Sandoz researchers. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].
Acceptable changes in quality for glycosylated biologicals
Research carried out by Sandoz into three glycosylated protein biotechnology drugs currently on the market showed quality changes over the period studied. Since all three drugs remained on the market with unchanged labels, this would indicate that the changes were accepted by the health authorities [1].
Etanercept and quality attributes changes
Quality changes in commercially available etanercept (Enbrel) were found by Sandoz researchers over a period of time. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].
