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• Innovators pointed to the EMA as having a de facto unique naming system.
• Innovators supported looking to the EMA for strict standards for approval.
• Innovators argued that significant bridging data should be required for any reliance on foreign data, even if the only difference in products is the source.
• Biosimilar proponents supported looking to foreign data with little bridging.
Exclusivity• The BPCIA allows approval of a new 12 year exclusivity
period for non-related entities for any structural change that results in a difference in purity, safety or potency.
• Some pointed out that the provision may conflict with Helsinky rules on replication of clinical trials by forcing duplicative human studies.
• One presenter noted that clarity is needed on whether after-filing acquisition of the applicant or licensing of the product by the original innovator relinquishes the new exclusivity.
• Innovators argued that this approval should be granted for any change, not just an improvement.
• Patient groups expressed worry in evergreening and the incentive to make minor improvements rather than new innovations
• One innovator requested that products that would qualify as biosimilar should not be able to skirt the 12 year exclusivity of the reference product by seeking approval as a new biologic.
• At the hearings, the representative for BIO asked that FDA interpret Sections (a) and (k) of the act as mutually exclusive, so a product that would qualify under the biosimilarity provisions of (k) not be granted approval under (a).
• Members of both houses of Congress have recently written FDA to emphasize that the exclusivity is “data” not “marketing” exclusivity, as the provision “does not prohibit or prevent another manufacturer from developing its own data to justify FDA approval.”
• Biosimilar proponents have since written to FDA to point out that the exclusivity provision has two separate periods of exclusivity — a four year period preventing filing of an abbreviated application under Section (k) (“data exclusivity”) and a twelve year period before an application can be approved under Section (k) (“marketing exclusivity”).