Reference biological product definition

Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
Reference biological product means the single biological product licensed pursuant to 42 U.S.C. 778 § 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food 779 and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 780 42 U.S.C. § 262(k).
Reference biological product means the biological product licensed pursuant to 42 USC 262(a) (12/0103/15/20212) against which a biological product is evaluated in an application submitted to the United States Food and Drug Administration for licensure of a biological product as a biosimilar product or for determination that a biosimilar product is interchangeable.¶

Examples of Reference biological product in a sentence

  • Reference biological product The term “reference biological product” means the biological product licensed under such section 262 of this title that is referred to in the application described in subparagraph (H) of the biosimilar biological product.


More Definitions of Reference biological product

Reference biological product means a single biological drug product registered under the Ghana Public Health Act 851 of 2012 against which a biosimilar product is evaluated. Contain an active biological substance with proven quality, safety and efficacy through non-clinical (toxicity) and clinical studies.
Reference biological product means the biological product licensed pursuant to
Reference biological product means the single biological product for which the
Reference biological product means the single biological product licensed pursuant to 42

Related to Reference biological product

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Licensed Product means any product or part thereof which: