FDA Issues Draft Guidance on Exclusivity Determinations for Biological Products | Practical Law

FDA Issues Draft Guidance on Exclusivity Determinations for Biological Products | Practical Law

The US Food and Drug Administration (FDA) issued draft industry guidance for biologics developers and other interested parties explaining how it will determine the date of first licensure for a biological product's regulatory exclusivity period.

FDA Issues Draft Guidance on Exclusivity Determinations for Biological Products

Practical Law Legal Update 6-578-2145 (Approx. 3 pages)

FDA Issues Draft Guidance on Exclusivity Determinations for Biological Products

by Practical Law Intellectual Property & Technology
Published on 14 Aug 2014 • USA (National/Federal)
The US Food and Drug Administration (FDA) issued draft industry guidance for biologics developers and other interested parties explaining how it will determine the date of first licensure for a biological product's regulatory exclusivity period.
On August 5, 2014, the US Food and Drug Administration (FDA) issued a draft guidance representing its current views on how it will determine the date of first licensure for biological products filed under 42 U.S.C. § 262(a) (79 FR 45448). The guidance provides sponsors who are developing biological products, sponsors of biologics license applications and other interested parties with a roadmap for distinguishing a new biologic from a previously-approved biologic and thereby obtaining a new exclusivity period. The guidance analyzes several statutory terms affecting the availability of a new exclusivity period, including how the FDA will determine:
  • Whether the new biologic's applicant is related to the sponsor of an approved biologic product.
  • Whether the new biologic involves a modified structure as compared to an approved product that changes its safety, purity or potency.
The FDA's guidance also identifies information sponsors can submit to assist the FDA's evaluation of these issues, including:
  • A list of all licensed biological products that are structurally related to the new biological product.
  • For each relevant licensed biologic, information concerning:
    • whether it is related to the sponsor or an affiliated entity;
    • how its structure differs from that of the new biologic; and
    • how its safety, purity or potency differs from that of the new biologic.
FDA must receive written and electronic comments regarding the draft guidance by October 6, 2014.