On August 4, 2014, the US Food and Drug Administration (FDA) released Draft Guidance on determining eligibility of a biological drug for regulatory exclusivity.
Under the Public Health Service Act (PHS Act), as amended in 2010, an abbreviated biosimilar application can be accepted by the FDA, but not until 4 years after the first licensure of the original reference product and, once accepted, such an application cannot be fully approved by the FDA for a period of 12 years from the reference’s first licensure. This reference product exclusivity is granted independently of any patent exclusivity, and therefore, by itself, provides a significant incentive to the sponsor of a Biologic License Application (BLA) who obtains the first licensure status. The date of first licensure is also critical to the timing of a follow-on biosimilar entry to the market.
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