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S. 3510IntroducedSenate · nowHousePresidentLawIn committee
Sec. 2 · S. 3510

Definitions

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In this Act— (1) the term biosimilar biological product means a biological product licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)); (2) the term biosimilar biological product establishment means an establishment engaged in the manufacture, preparation, propagation, or processing of a biosimilar biological product and registered under subsection (b)(1), (c)(1), or (i) of section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360); and (3) the term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.