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.

Greetings from beautiful Vancouver, British Columbia where the 4th IATA World Cargo Symposium is about to get underway.

It seems like I'm constantly running a day behind. So before getting consumed in pharmaceutical air cargo issues, I thought I would take a moment to link you to my latest Contract Pharma article. For all the controversy that can surround industry award competitions, the net gain here is that the patient ultimately benefits — and regardless of what you think about industry awards, that is a very good thing. The 2010 IQPC Cool Chain Excellence Awards.

Keep it real.

There has been much discussion (and confusion) regarding the applicability of MKT in the handling, storage and distribution of temperature-sensive pharmaceuticals over the past 18 months or so. Late last spring, a posse of five industry experts published a paper to add clarity to this often confusing topic. The group consisted of an Eli Lilly & Company engineer, regulatory scientist, a retired QA / Technical Support Director, and a Research Advisor, who collaborated with a Distribution QA Director from Abbott Laboratories. Their five page article was published in the May/June issue of Pharmaceutical Outsourcing Magazine.

At issue, and the answers the authors strove to assess and resolve was: can the impact of a reuslting MKT from excursions encountered over short periods of time, (excessive heat exposure during transport for example), have a significant impact on product degredation or quality?

The paper does an excellent job of illustrating the importance of establishing upper and lower limits on the use of MKT based on available stability data. The authors conclude that under certain circumstances it can be appropriate to use the calculated Mean Kinetic Temperature for a drug product as a valid means to approximate the effects of temperature variation that may occur during transport in the absence of product specific kinetic data, but that it is limited to temperatures for which there are stability data to support it, and not beyond.

The entire article has been made available in a printable pdf format (click on the paper clip icon below) thanks to the kind permission of the authors, Bob Seevers, Ph.D., Jeffery Hofer, Paul Harber, and Rafik Bishara, Ph.D. , David Ulrich; Nathan Collins, Editor Russell Publishing, and Henry Ames at Sensitech..