Sec. 208. Change in definition of strength for the purposes of determining interchangeability of biological and biosimilar products
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Section 351(i) of the Public Health Service Act is amended by inserting the following after paragraph (4): The term strength , in reference to a biological product intended for administration by injection, means the total content of drug substance in the dosage form without regard to the concentration of drug substance or total volume of the biological product. . Section 351(k)(7)(C)(ii)(I) of the Public Health Service Act is amended by inserting “concentration,” after “delivery device,”.