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Under the second alternative, which we finalized in section III.A.2 of this rule, we will set the payment limit for a given quarter using the biosimilar's most recently available positive ASP data and either 6 percent (or 8 percent for qualifying biosimilar biologicals) 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

Metabolic Pharmaceuticals Phase I (, ) Phase II ()

[DOI] [PMC free article] [PubMed] [Google Scholar] 258.Garca-Granja P.E., Veras C., Aparisi ., Amat-Santos I.J., Catal P., Marcos M., Cabezn G., Candela J., Gil J.F., Uribarri A., et al