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.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78

The Pharma Data

DECEMBER 27, 2020

The drug is a topical ointment applied to the lower lid to address the build-up and shedding of proteins at the opening of the Meibomian gland. ATYR1923 is a fusion protein made up of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody.

Trials 52

Trials Antibody Gene Therapy Clinical Trials 52

Pharmaceutical Technology

FEBRUARY 23, 2023

The BCS is a regulatory tool that is used to justify clinical biowaivers for certain types of compounds (BCS Class I and III) based on dissolution data, allowing sponsors to justify not performing clinical bioequivalence studies when changing a formulation.

Development 246

Development Drugs Bioavailability In-Vivo 246