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Summary of Final Guidance on Interchangeability of Biosimilars With Reference Products

USA - May 28 2019 On May 10, 2019, the U.S. Food and Drug Administration (FDA) released nonbinding final Guidance for Industry, Considerations in Demonstrating…

Linda A. Wadler

USP Will Not Revise Its Biologics Monograph Without Stakeholder Consensus

USA - April 18 2018 On April 2, 2018, the United States Pharmacopeial Convention (“USP”) issued a statement that it will not develop a new monograph for a biologic unless…

Federal Circuit Speaks Regarding State Law Remedy for BPCIA’s “Patent Dance”

USA - December 18 2017 On December 14, 2017, the Federal Circuit issued a unanimous decision in Amgen Inc. v. Sandoz Inc., No. 2015-1499,[1] interpreting whether the…

Summary of FDA Guidance on Statistical Approaches to Evaluate Analytical Similarity

USA - October 5 2017 On September 21, 2017, the U.S. Food and Drug Administration released a nonbinding draft guidance for industry, Statistical Approaches to Evaluate…

Linda A. Wadler

Sandoz v. Amgen Supreme Court Decision

USA - June 14 2017 On June 12, 2017, the U.S. Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195,1 interpreting two provisions…