Reference biological product definition

Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
Sample 1Sample 2Sample 3
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).
Sample 1Sample 2Sample 3
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.¶
Sample 1Sample 2

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.
Sample 1Sample 2Sample 3
Reference biological product means the biological product licensed pursuant to
Sample 1Sample 2
Reference biological product means the biological product licensed pursuant to 42 U.S.C. 262(a)
Sample 1
Reference biological product means the single biological product for which the
Sample 1
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.
Sample 1

Related to Reference biological product

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • 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.

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

  • 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.

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