Strategies to control therapeutic antibody glycosylation during bioprocessing: Synthesis and separation

E Edwards, M Livanos, A Krueger, A Dell… - Biotechnology and …, 2022 - Wiley Online Library
Glycosylation can be a critical quality attribute in biologic manufacturing. In particular, it has
implications on the half‐life, immunogenicity, and pharmacokinetics of therapeutic …

[HTML][HTML] Why is there no biosimilar of Erbitux®?

E Douez, V D'atri, D Guillarme, D Antier… - … of Pharmaceutical and …, 2023 - Elsevier
Monoclonal antibody (mAb)-based therapies have been a major advance in oncology
patient care, even though they represent a significant healthcare cost. Biosimilars, launched …

Spending, utilization, and price trends for immune checkpoint inhibitors in US medicaid programs: an empirical analysis from 2011 to 2021

YE Shin, A Kumar, JJ Guo - Clinical Drug Investigation, 2023 - Springer
Abstract Background and Objective Immune checkpoint inhibitors (ICIs) have become a
cornerstone in cancer treatment. With high treatment costs and an increasing number of …

Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal …

JY Reginster, E Czerwinski, K Wilk, P Borowy… - Osteoporosis …, 2024 - Springer
Abstract Summary This 78-week (18-month) study conducted in 479 postmenopausal
women with osteoporosis evaluated the efficacy, pharmacodynamics, pharmacokinetics …

Oncology biosimilars: New developments and future directions

RD Bachu, M Abou‐Dahech, S Balaji… - Cancer …, 2022 - Wiley Online Library
Biologicals have become an integral part of cancer treatment both as therapeutic agents and
as supportive care agents. It is important to know that biologics are large, complex molecular …

State-of-the-art native mass spectrometry and ion mobility methods to monitor homogeneous site-specific antibody-drug conjugates synthesis

E Deslignière, A Ehkirch, BL Duivelshof, H Toftevall… - Pharmaceuticals, 2021 - mdpi.com
Antibody-drug conjugates (ADCs) are biotherapeutics consisting of a tumor-targeting
monoclonal antibody (mAb) linked covalently to a cytotoxic drug. Early generation ADCs …

Pertuzumab charge variant analysis and complementarity-determining region stability assessment to deamidation

B Spanov, O Olaleye, T Mesurado… - Analytical …, 2023 - ACS Publications
Pertuzumab is a monoclonal antibody used for the treatment of HER2-positive breast cancer
in combination with trastuzumab. Charge variants of trastuzumab have been extensively …

A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab

M Hummel, T Bosje, A Shaw, MS Liu, A Barve… - Journal of Cancer …, 2022 - Springer
Purpose Bevacizumab is a recombinant humanized monoclonal antibody that inhibits
vascular endothelial growth factor-specific angiogenesis in some cancers. MYL-1402O is a …

Comparative efficacy and safety of trastuzumab biosimilars to the reference drug: a systematic review and meta-analysis of randomized clinical trials

S Cargnin, JI Shin, AA Genazzani, A Nottegar… - Cancer Chemotherapy …, 2020 - Springer
Purpose To assess efficacy and safety of trastuzumab biosimilars in comparison to the
reference drug through a systematic review and meta-analysis of randomized controlled …

The potential immune regulation benefit of CpAMs beyond HBV suppression

D Wu, W Yan, M Han, Q Ning - The Lancet Gastroenterology & …, 2021 - thelancet.com
Current approved antiviral therapies for chronic hepatitis B virus (HBV) infection are limited
to either nucleotide or nucleoside analogues or pegylated interferon α, all of which can …