The H.R. 3590 Sec. 7002, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a new category of biological products, biosimilars, having a similar safety and efficacy profile as a US-licensed reference product. The BPCIA was approved as part of the Affordable Healthcare Act, after years of politicking in the US Congress without any resolution as big pharma kept pushing its approval. In 2008, when Barack Obama was elected President, I wrote a personal letter to him that is now in the Obama Library in Chicago, where I found the privilege of advising him on the need for this legislation and apprised him on the critical elements of the bill that needed to be kept intact. President Obama was convinced that a seven-year exclusivity period for new biologics should suffice, as I had recommended; but then the political pressure came into play, and he reluctantly agreed to a 12-year exclusivity. The frenzy that preceded the passage of the Affordable Healthcare Act, wherein the BPCIA was a minor add-on, perhaps escaped the scrutiny of many vested interests, yet, some elements that should not have been in the bill, could not be deleted—most prominently, the dual classification of biosimilars, as biosimilars and interchangeable biosimilars, the latter requiring testing that would prove to be irrelevant and scientifically irrational.

I have continued to write about the slow entry of biosimilars to the US markets and continue to hope that someday we will be able to find a rational approach to make biosimilars affordable.

This letter is in the Obama Libraray in Chicago. .