The 2.409 page Patient Protection and Affordable Care Act, (HB 3590), passed by the U. S. Congress on Sunday, March 21, 2010  includes a section establishing at long last, a pathway for FDA approval of biosimilar versions of previously approved biological products.  This provision, Title VII- Providing Access to Innovative Medical Therapies, "prohibits the approval of an application as either biosimilar or interchangeable until 12 years from the date on which the reference product is first approved. In addition, it stipulates an additional 6 months of exclusivity for the use of reference products "in the pediatric population." 

This is considered a victory for industry associations such as BIO and PhRMA who initially sought 14 years of patent exclusivity and a disappointment to biosimilar manufacturers who would like to have settled on 7 years before entering the lucrative biologicals market and who have made the claim that such competition can drive down the cost for these miracle therapies by as much as 30%. 

Title VII is not a section of healthcare reform known to most Americans who have been trying to wrap their minds around the enormous implications of this bill as they waded through the incessant political rhetoric and partisanship in recent months. In fact, I have listened to quite a bit of debate on this bill and watched a more than a few hours of coverage on C-Span, and not once did I hear mention of Title VII. It does however, hold considerable weight for the biopharmaceutical industry as a whole and ultimately, the American patient population.(See my previous posts: Advanced Degrees: Following up On Follow-On Biologics (Sep '09) and Advanced Degrees: You Say "Generic," I Say Follow-On" (Jul '09))

News media would much rather focus on what they believe is the one and only important consideration to the American populace - insurance costs. By chasing this, and other red herrings, and essentially ignoring most other elements of the bill, the significance and implications of this Act on the future of healthcare has been clouded, if not obscured entirely. No doubt it is a monumental piece of legislation, literally and figuratively. There are a number of websites that have condensed and objectively summarized the bill for easier reading and understanding. Trouble is, most Americans won't bother to take the time to educate themselves. There's the real tragedy.