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Showing 1 to 7 of 7 entries
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Investigation of the Physicochemical and Biological Stability of the Adalimumab Biosimilar CT-P17.

Advances in therapy

Shin YK, Han WY, Kim SJ, Kim KW, Roh JW, Lee JB, Oh JS, Astier A.
PMID: 34618346
Adv Ther. 2021 Nov;38(11):5609-5622. doi: 10.1007/s12325-021-01929-x. Epub 2021 Oct 07.

INTRODUCTION: CT-P17 (Celltrion, Inc., Incheon, Republic of Korea) is a biosimilar of reference adalimumab (HumiraMETHODS: This analysis was designed to evaluate the stability profile of CT-P17 compared with reference adalimumab and the currently licensed adalimumab biosimilars ABP 501 (AmjevitaRESULTS:...

Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab.

mAbs

Lee N, Lee JJ, Yang H, Baek S, Kim S, Kim S, Lee T, Song D, Park G.
PMID: 30296198
MAbs. 2019 Jan;11(1):129-144. doi: 10.1080/19420862.2018.1530920. Epub 2018 Oct 19.

Biosimilars are biologic products that are highly similar to a licensed reference product in terms of quality, safety, and efficacy. SB5 is a biosimilar of Humira® (adalimumab) developed by Samsung Bioepis. To demonstrate its biosimilarity in quality to Humira®,...

Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study.

Biologicals : journal of the International Association of Biological Standardization

Alsamil AM, Giezen TJ, Egberts TC, Leufkens HG, Gardarsdottir H.
PMID: 33454195
Biologicals. 2021 Jan;69:30-37. doi: 10.1016/j.biologicals.2020.12.003. Epub 2021 Jan 13.

Biosimilar approval relies on the comparability of quality attributes (QAs), for which information can be derived from regulatory or scientific communities. Limited information is known about whether these sources are consistent with or complementary to each other. The consistency...

Mining Potential Effects of HUMIRA in Twitter Posts Through Relational Similarity.

Studies in health technology and informatics

Jiang K, Feng S, Huang L, Chen T, Bernard GR.
PMID: 32570507
Stud Health Technol Inform. 2020 Jun 16;270:874-878. doi: 10.3233/SHTI200286.

HUMIRA, a biologic therapy, has been approved to treat autoimmune diseases and been marketed in many countries worldwide. Much like other medications, it demonstrates many effects on the human body. It is important to understand its effects from the...

Overview of Humira® Biosimilars: Current European Landscape and Future Implications.

Journal of pharmaceutical sciences

Coghlan J, He H, Schwendeman AS.
PMID: 33556387
J Pharm Sci. 2021 Apr;110(4):1572-1582. doi: 10.1016/j.xphs.2021.02.003. Epub 2021 Feb 05.

Humira® (adalimumab) by AbbVie has been the top-selling biologic drug product for the last few years - reaching nearly $20 billion in annual sales in 2018. Upon the October 2018 release of four adalimumab biosimilars into the European market,...

Effectiveness and safety of switching to adalimumab biosimilar ABP 501 in Crohn's disease: the extrapolation concept.

Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

Ribaldone DG, Vernero M, Astegiano M.
PMID: 33207912
Rev Esp Enferm Dig. 2021 Feb;113(2):155. doi: 10.17235/reed.2020.7253/2020.

We sincerely thank Viscido et al. for their appropriate and sharable comments on our recent study on adalimumab biosimilar ABP 501 in Crohn's disease (CD). The use of a biosimilar in inflammatory disorders is one of the current main...

Comprehensive characterisation of the heterogeneity of adalimumab via charge variant analysis hyphenated on-line to native high resolution Orbitrap mass spectrometry.

mAbs

Füssl F, Trappe A, Cook K, Scheffler K, Fitzgerald O, Bones J.
PMID: 30296204
MAbs. 2019 Jan;11(1):116-128. doi: 10.1080/19420862.2018.1531664. Epub 2018 Nov 11.

Charge variant analysis is a widely used tool to monitor changes in product quality during the manufacturing process of monoclonal antibodies (mAbs). Although it is a powerful technique for revealing mAb heterogeneity, an unexpected outcome, for example the appearance...

Showing 1 to 7 of 7 entries