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On August 13, 2025, CMS released updated CMS Medicare Part B vaccine payment allowance limits for the 2025 to 2026 influenza season, effective August 1, 2025, through July 31, 2026

We believe including the reference product's data in the blended calculation for a biosimilar's payment limit in the limited circumstance described could be appropriate in determining an operationally reasonable payment limit because the FDA approval for the biosimilar relies in part on FDA's previous determination of safety, purity, and potency for the reference product, and the biosimilar is necessarily approved for at least one condition of use that has been previously approved for its reference product, as required under the 351(k) approval pathway

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People with behavioral tolerance can appear sober even after drinking a significant amount of alcohol and may have better control over their speech, movement, appearance, and emotional state compared to inexperienced drinkers