Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, […]readmore
Tags : Bio-Thera
Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & EU-sourced in normal healthy candidates The clinical […]readmore
1. Triumvira’s TAC01-CD19 Receives FDA’s Fast Track Designation for R/R Diffuse Large B-Cell Lymphoma Published: Nov 07, 2019 | Tags: Triumvira, TAC01-CD19, Receives, FDA, Fast Track Designation, R/R, Diffuse Large B-Cell […]readmore
Shots: The approval of QLETLI is based on P-III study resulted in meeting its 1EPs, demonstrating bio-similarity to the reference product, Humira (adalimumab) including clinical/nonclinical, PK/PD data The approval of […]readmore
Shots: Cipla to get exclusive commercialization rights for Bio-Thera’s BAT1706 in certain countries. Bio-Thera will be responsible for its development & product approval with FDA & EMA In 2020, Bio-Thera […]readmore