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) (v. 03/1512/28/2022) 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

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.
Sample 1Sample 2Sample 3
Reference biological product means the biological product licensed pursuant to
Sample 1Sample 2
Reference biological product means the single biological product for which the
Sample 1

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).

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

  • Combination Product means a Licensed Product that is comprised of or contains a Licensed Compound as an active ingredient together with one (1) or more other active ingredients or Delivery Systems and is sold either as a fixed dose/unit or as separate doses/units in a single package.

  • 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.

  • 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 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.