The head of the US Food and Drug Administration has said that even if the US Congress approves legislation paving the way for generic copies of biologic drugs, the biosimilars would not be interchangeable for the brand-name biologics.
Speaking at the annual meeting of the Pharmaceutical Research and Manufacturers of America, FDA commissioner Andrew von Eschenbach said that biogenerics would be considered only ‘similar’ to brand-name drugs and not freely-substitutable copies. "We recognise that the end point would be what could be best described as similarity," he said. "Similarity in the sense that when a doctor gives you the product – delivered it to a patient – it will achieve an effect that is similar to the effect that we expected from" the brand-name drug.
That follows the approach adopted by the European Union, and it is a strategy that is favoured by Democrat Senator Edward Kennedy who has been chairing the Senate Health, Education, Labor and Pensions (HELP) Committee which has been looking at creating a pathway for the FDA to back follow-on versions of biologic drugs. However other US politicians have taken the line that the European way is too cautious and Democrat Senator Charles Schumer, co-sponsor with Senator Hillary Clinton and Congressman Henry Waxman of the bipartisan Access to Life-Saving Medicines Act (S 623) which would give the FDA this authority, recently said that “as it stands today, the EU has a highly-regulated process in place that has, arguably, been unnecessarily burdensome to competitors and has only resulted in two approvals to date.”
Amgen chief executive Kevin Sharer, who was re-elected chairman of the board of PhRMA at the trade association's annual meeting, said that “our growing knowledge of human genetics and advances in modern biology offer great promise for the development of new treatments and cures. To deliver on that promise, we need public policies that stimulate and reward innovation and assure patient access to those breakthrough medicines."