Companies Want FDA To Make Early Biologic Exclusivity Determinations

October 16, 2014 at 7:34 PM
Companies developing biologics want FDA to begin the process of determining biologic exclusivity earlier than it has planned in recent draft guidance and assert that the agency has gone beyond its statutory mandate in asking them to prove their product's exclusivity instead of automatically granting it. Biosimilar sponsors seeking to copy innovator drugs want the ability to request and weigh in on exclusivity determinations, and to ensure the process does not lead to "evergreening" -- constantly extending the product's market...


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