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