Literature DB >> 33556387

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

Jill Coghlan1, Hongliang He1, Anna S Schwendeman2.   

Abstract

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, those sales began to shrink. By the end of 2019, the annual sales of Humira®, albeit still high, dipped closer to $19 billion as nearly 35% of European patients had been switched from Humira® to a biosimilar. Diminishing sales are expected to continue as the adoption of adalimumab biosimilars increases in Europe and Humira®'s patent protection is lost in the United States come 2023. In this review we discuss how impactful the availability of biosimilars has been to the European adalimumab market approximately two years after their release. We further analyze the marketed biosimilars with regards to differences in their formulation, delivery devices, biological activity, physicochemical properties, clinical trials data, and current financial foothold. More importantly, though, we highlight how "similar" these biosimilars are to Humira®. In doing so, we seek to educate the public on what they may be able to expect once adalimumab biosimilars enter the United States market in 2023.
Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Antibody drug(s); Biosimilar(s); Clinical trial(s); Formulation; Physicochemical properties

Mesh:

Substances:

Year:  2021        PMID: 33556387      PMCID: PMC8014989          DOI: 10.1016/j.xphs.2021.02.003

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN: 0022-3549            Impact factor:   3.534


  32 in total

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Review 2.  Scientific and statistical considerations in evaluating the analytical similarity of ABP 501 to adalimumab.

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Journal:  Anal Chem       Date:  2017-04-17       Impact factor: 6.986

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7.  Impact of a Patient Support Program on Patient Adherence to Adalimumab and Direct Medical Costs in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis.

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Journal:  J Manag Care Spec Pharm       Date:  2017-03-15

8.  A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis.

Authors:  Roy M Fleischmann; Rieke Alten; Margarita Pileckyte; Kasia Lobello; Steven Y Hua; Carol Cronenberger; Daniel Alvarez; Amy E Bock; K Lea Sewell
Journal:  Arthritis Res Ther       Date:  2018-08-15       Impact factor: 5.156

9.  Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

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Journal:  Ann Rheum Dis       Date:  2017-06-05       Impact factor: 19.103

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Journal:  Pharmacol Res Perspect       Date:  2016-01-15
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  2 in total

1.  Increase recombinant antibody yields through optimizing vector design and production process in CHO cells.

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Journal:  Appl Microbiol Biotechnol       Date:  2022-07-05       Impact factor: 5.560

2.  Rapid intensification of an established CHO cell fed-batch process.

Authors:  Markus Schulze; Julia Niemann; Rene H Wijffels; Jens Matuszczyk; Dirk E Martens
Journal:  Biotechnol Prog       Date:  2021-09-25
  2 in total

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