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The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. ...more
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more