Monday, March 29, 2010

Biosimilars In Recently Passed Healthcare Bill

I was really surprised to find out that biosimilars are included in the recently passed healthcare bill, Patient Protection and Affordable Care Act.  I learned about this while reading Kevin O'Donnell's post on his blog (Where cooler heads prevail), "New U.S. Healthcare Bill Includes Pathway for Biosimilars and 12 Year Patent Exclusivity."

Kevin writes:

"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.""
References:
Full text of the Patient Protection and Affordable Care Act HR 3590

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