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. 761 § 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food 762 and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 763 42 U.S.C. § 262(k).
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Reference biological product means the biological product licensed pursuant to 42 USC 262(a) (12/01/2021)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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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 biological product licensed pursuant to 42 U.S.C. 262(a)
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Reference biological product means the single biological product for which the
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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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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 any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • 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, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.