Reference biological product definition

Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
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Reference biological product means the single biological product licensed pursuant to 42 U.S.C. 944 § 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food 945 and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 946 42 U.S.C. § 262(k).
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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.¶
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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.
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Reference biological product means the biological product licensed pursuant to
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Reference biological product means the single biological product for which the United States Food and Drug Administration has approved an initial biological product license application, against which other biological products are evaluated for licensure as biosimilar products or interchangeable biological products.
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Reference biological product means the single biological product for which the
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Reference biological product means the biological product licensed pursuant to 42 U.S.C. 262(a)
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Related to Reference biological product

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

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

  • Combination Product means a product that includes a device for delivery or at least one active ingredient other than a Licensed Product.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

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

  • Commercial Product means any such product as defined in FAR 2.101.

  • 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 a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).