Qualifying biosimilar biological product

Qualifying biosimilar biological product means a biosimilar biological product (as described in section 1847A(1)(C) of the Act) with an average sales price (as described in section 1847A(b)(8)(A)(i) of the Act) less than the average sales price of the reference biological for a calendar quarter during the applicable 5-year period.

Source

42 CFR § 414.902

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Scoping language

As used in this subpart, unless the context indicates otherwise

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