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Biosimilars With Only Negative or Zero Manufacturer's ASP Data In circumstances in which negative or zero manufacturer's ASP data is reported for all NDCs for a biosimilar biological product (defined at 414.902) (hereinafter referred to as a biosimilar) for a given quarter (and at least one NDC for the biosimilar is actively being marketed (that is, not discontinued)), and positive manufacturer's ASP data is available for another biosimilar(s) with the same reference biological product (hereinafter referred to as a reference product) for the given quarter, we are proposing to set the payment limit for the given quarter equal to the sum of the following until at least one NDC for the particular biosimilar for which all NDCs report negative or zero manufacturer's ASP data has positive manufacturer's ASP data for a quarter: The volume-weighted average of the positive manufacturer's ASP data from all other biosimilars with the same reference product, and 6 percent (or 8 percent for qualifying biosimilar biologicals as defined in 414.902, as appropriate) of the amount determined under section 1847A(b)(4) of the Act for the reference biological product (as defined in 414.902) for the given quarter

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