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Conference

4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

Articles

FDA Draft Guidance on Evaluation of Therapeutic Equivalence FDA Draft Guidance on Evaluation of Therapeutic Equivalence

Federal Circuit IP Blog

Supplements to Biologics License Application Do Not Trigger New Notice Obligation under Section 262(l)(8)(A) Supplements to Biologics License Application Do Not Trigger New Notice Obligation under Section 262(l)(8)(A)

Event

Love It AND List It—What’s New with the Orange Book and Hatch-Waxman Litigation Love It AND List It—What’s New with the Orange Book and Hatch-Waxman Litigation

Articles

Considerations in Demonstrating Interchangeability with a Reference Biologic Product Considerations in Demonstrating Interchangeability with a Reference Biologic Product

Articles

New FDA Guidance On Biosimilar Interchangeability New FDA Guidance On Biosimilar Interchangeability