Evaluation of analytical similarity between trastuzumab biosimilar CT-P6 and reference product using statistical analyses

MAbs
Jihun LeeShin Jae Chang

Abstract

The evaluation of analytical similarity has been a challenging issue for the biosimilar industry because the number of lots for reference and biosimilar products available at the time of development are limited, whilst measurable quality attributes of target molecule are numerous, which can lead to potential bias or false negative/positive conclusions regarding biosimilarity. Therefore, appropriate statistical analyses are highly desirable to achieve a high level of confidence in the similarity evaluation. A recent guideline for the risk-based statistical approaches recommended by the US Food and Drug Administration provides useful tools to systematically evaluate analytical similarity of biosimilar products compared with reference products. Here, we evaluated analytical similarity of CT-P6, a biosimilar product of trastuzumab, with the reference products (EU-Herceptin® or US-Herceptin®) following these statistical approaches. Various quality attributes of trastuzumab were first ranked based on the clinical impact of each attribute and subsequently adjusted to one of three tiers (Tier 1, Tier 2 and Tier 3) considering the characteristics of the assay, the level of attribute present and the feasibility of statistical analysis. T...Continue Reading

References

May 15, 1992·Proceedings of the National Academy of Sciences of the United States of America·P CarterH M Shepard
Sep 1, 1993·Cancer Immunology, Immunotherapy : CII·G D LewisH M Shepard
Aug 1, 1996·Nature Biotechnology·N JenkinsD C James
Mar 31, 2000·Nature Medicine·R A ClynesJ V Ravetch
Mar 13, 2001·Annual Review of Immunology·J V Ravetch, S Bolland
Mar 29, 2001·Journal of Chromatography. B, Biomedical Sciences and Applications·R J HarrisA B Chen
Nov 11, 2003·The Journal of Immunology : Official Journal of the American Association of Immunologists·Bernhard StockmeyerMartin Herrmann
Sep 10, 2004·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Roberto GennariAlberto Costa
Oct 30, 2004·Biotechnology and Bioengineering·Katsuhiro MoriMitsuo Satoh
Mar 1, 2005·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Armando J CordobaReed J Harris
May 21, 2005·Biotechnology Progress·Royston Jefferis
Dec 3, 2005·Biotechnology Progress·Jason HodoniczkyDavid C James
May 10, 2006·Nature Clinical Practice. Oncology·Rita NahtaFrancisco J Esteva
Oct 10, 2006·The AAPS Journal·Amy S Rosenberg
Nov 23, 2006·Analytical Biochemistry·Keith A JohnsonJason C Rouse
Jan 19, 2007·Annals of Oncology : Official Journal of the European Society for Medical Oncology·G ValabregaM Aglietta
Mar 17, 2007·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Eiji SuzukiMasakazu Toi
Dec 8, 2007·Nature Reviews. Immunology·Falk Nimmerjahn, Jeffrey V Ravetch
Jun 26, 2009·Trends in Pharmacological Sciences·Royston Jefferis
Dec 8, 2009·Trends in Pharmacological Sciences·Melody SauerbornHuub Schellekens
Apr 12, 2011·Nature Biotechnology·Martin SchiestlRoger Grau
Aug 6, 2011·AJNR. American Journal of Neuroradiology·J J Gemmete, S K Mukherji
Nov 8, 2011·Annals of Oncology : Official Journal of the European Society for Medical Oncology·D M CollinsJ Crown
Apr 19, 2012·Analytical Chemistry·Alain BeckAlain Van Dorsselaer
Jun 22, 2012·Frontiers in Oncology·Thuy Vu, Francois X Claret
May 8, 2013·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Jan VisserMartin Schiestl
May 20, 2015·Trends in Immunology·Falk NimmerjahnAnja Lux

❮ Previous
Next ❯

Citations

Sep 12, 2019·Expert Opinion on Biological Therapy·Chen FuFrancisco J Esteva
Jan 25, 2020·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Srishti Joshi, Anurag S Rathore
Apr 6, 2019·Pharmacology & Therapeutics·Emiliano CoccoMaurizio Scaltriti
Mar 18, 2021·Journal of Pharmaceutical and Biomedical Analysis·Alexis Oliva, Matías Llabrés
Aug 26, 2021·Expert Opinion on Biological Therapy·Anurag Rathore, Himanshu Malani
Nov 10, 2021·Bioprocess and Biosystems Engineering·Amélie MahéPierre-Alain Girod

❮ Previous
Next ❯

Methods Mentioned

BETA
amidation
enzyme linked immunosorbent assay
ELISA
surface plasmon resonance
glycosylation
deamidation
differential scanning calorimetry
light scattering
ion exchange chromatography
circular dichroism

Software Mentioned

SEDFIT
Quantity One
GraphPad Prism®
PLA
Origin
BIAevaluation
PASS
SAS

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Biologicals : Journal of the International Association of Biological Standardization
Ohseok KwonSeung Hwa Hong
© 2022 Meta ULC. All rights reserved