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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