Pharmaceutical Technology
OCTOBER 28, 2022
To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.
Camargo
NOVEMBER 11, 2020
The ANDA application must contain a basis of submission specifying the RLD, and the applicant must show that the proposed generic drug is the same as the RLD with respect to active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
FEBRUARY 26, 2024
314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” FDA explained that its bioequivalence regulations at 21 C.F.R. FDA borrowed this definition from 21 C.F.R.
The Pharma Data
DECEMBER 28, 2020
Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. However, not all forward-looking statements contain these words. ” According to IQVIA, the U.S.
Camargo
DECEMBER 13, 2021
An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.
The Pharma Data
FEBRUARY 1, 2021
The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. percent vs. 32.1 MS, the coronavirus and vaccines – updated global advice. Available at: [link] Accessed: January 2021.
Delveinsight
FEBRUARY 5, 2021
Some of these approved products contain nicotine as an active ingredient, while others do not. Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Two doses, bupropion XL 15 mg and bupropion XL 300 were approved.
Expert insights. Personalized for you.
130 
Let's personalize your content