Biologic Product Exclusivity Decisions Will Involve Sponsor Dialogue, FDA Says

While FDA has laid out the types of information it wants sponsors to provide, agency acknowledges it cannot easily write guidance stating the extent of structural changes to a molecule that would justify a new period of exclusivity.

FDA expects to have conversations with individual sponsors as it decides whether an approved biologic qualifies for reference product exclusivity under the Biologics Price Competition and Innovation Act.

Speaking at a DIA biosimilars meeting in Washington, D.C. Sept. 19, FDA Office of New Drugs Associate Director for Therapeutic...

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