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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

( ( ( We proposed to implement the changes described in this section through revisions to 425.652 and the addition of 425.662

However, the 8mg dose requires 160 units (1.6mL), necessitating a split into two separate draws