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BioDrugs : Clinical Immunotherapeutics,... Dec 2018GP2017 (adalimumab) is a biosimilar anti-TNF-α antibody. It is approved in the EU for use in all indications for which reference adalimumab is approved. GP2017 has... (Review)
Review
GP2017 (adalimumab) is a biosimilar anti-TNF-α antibody. It is approved in the EU for use in all indications for which reference adalimumab is approved. GP2017 has similar physicochemical and functional properties to those of reference adalimumab, and the pharmacokinetic similarity of the agent has been shown in healthy male volunteers. GP2017 demonstrated clinical efficacy equivalent to that of reference adalimumab in patients with moderate to severe plaque psoriasis or rheumatoid arthritis; the tolerability, safety and immunogenicity profiles of the two agents were also similar. Multiple switching between GP2017 and reference adalimumab (up to four times) had no impact on efficacy, tolerability or immunogenicity. The role of reference adalimumab in the management of autoimmune inflammatory conditions is well established and GP2017 provides an effective biosimilar alternative for patients requiring adalimumab therapy.
Topics: Adalimumab; Autoimmune Diseases; Biosimilar Pharmaceuticals; Drug Substitution; Humans; Treatment Outcome; Tumor Necrosis Factor-alpha
PubMed: 30460599
DOI: 10.1007/s40259-018-0318-x -
Journal of Comparative Effectiveness... Nov 2023The patent expiry of Humira in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita, Amsparity, Hulio, Hukyndra,... (Review)
Review
The patent expiry of Humira in 2018 opened up the current European market to eight adalimumab biosimilars - (in alphabetical order) Amgevita, Amsparity, Hulio, Hukyndra, Hyrimoz, Idacio, Imraldi and Yuflyma - for the treatment of various immune and inflammatory conditions. Amjevita, Hadlima, Hyrimoz and Yuflyma have recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humira ends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient-physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals; Expert Testimony; Europe
PubMed: 37855223
DOI: 10.57264/cer-2023-0117 -
BioDrugs : Clinical Immunotherapeutics,... Oct 2018SB5 (Imraldi) is a biosimilar of the reference anti-TNF monoclonal antibody adalimumab. It is approved for use in the following indications for which reference... (Review)
Review
SB5 (Imraldi) is a biosimilar of the reference anti-TNF monoclonal antibody adalimumab. It is approved for use in the following indications for which reference adalimumab is approved: rheumatoid arthritis (RA), juvenile idiopathic arthritis [polyarticular juvenile idiopathic arthritis (pJIA) and enthesitis-related arthritis (ERA)], axial spondyloarthritis [ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)], psoriatic arthritis (PsA), psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn's disease, pediatric Crohn's disease, ulcerative colitis (UC), and non-infectious uveitis. SB5 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and the pharmacokinetic similarity of these agents has been shown in healthy volunteers and patients with RA. SB5 demonstrated clinical efficacy considered equivalent to that of reference adalimumab in patients with RA, and was generally well tolerated in this population. The safety and tolerability profile of SB5 was similar to that of reference adalimumab, as was the immunogenicity profile. Switching from reference adalimumab to SB5 had no impact in terms of efficacy, safety or immunogenicity. The role of reference adalimumab in the management of RA, pJIA, ERA, AS, nr-axSpA, PsA, psoriasis, pediatric plaque psoriasis, HS, Crohn's disease, UC and non-infectious uveitis is well established and SB5 provides an effective biosimilar alternative for patients requiring adalimumab therapy.
Topics: Adalimumab; Antirheumatic Agents; Arthritis, Rheumatoid; Biosimilar Pharmaceuticals; Colitis, Ulcerative; Crohn Disease; Humans; Psoriasis; Spondylarthritis; Spondylitis, Ankylosing
PubMed: 30251234
DOI: 10.1007/s40259-018-0307-0 -
The Journal of the Association of... May 2017A first fully humanized monoclonal antibody approved by US Food and Drug Administration (FDA) in 2002 was Adalimumab. Clinical efficacy and safety of adalimumab has been... (Review)
Review
A first fully humanized monoclonal antibody approved by US Food and Drug Administration (FDA) in 2002 was Adalimumab. Clinical efficacy and safety of adalimumab has been assessed in various trials in rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn's Disease, and ulcerative colitis. It is one of the major sales success among biological and still one of the greatest blockbuster amongst monoclonal antibodies. With the advent of patent expiry of the parent drug HUMIRA, several potential biosimilars have debuted in various markets worldwide. Present article will discuss current situation of molecules that are front-runners to become adalimumab biosimilars with particular stress on Indian market and ZRC3197 (Adalimumab Biosimilar).
Topics: Adalimumab; Anti-Inflammatory Agents; Arthritis; Biosimilar Pharmaceuticals; Clinical Trials as Topic; Colitis, Ulcerative; Crohn Disease; Drug Approval; Humans; Pharmacovigilance
PubMed: 28836746
DOI: No ID Found -
The American Journal of Gastroenterology Jan 2021Over the past 2 decades, biological therapy with monoclonal antibodies targeting tumor necrosis factor-α has become a cornerstone of treatment of patients with... (Review)
Review
Over the past 2 decades, biological therapy with monoclonal antibodies targeting tumor necrosis factor-α has become a cornerstone of treatment of patients with inflammatory bowel disease. Although clinically effective, the biological therapies remain expensive, and their availability and utilization have been at times limited due to their high costs. Biosimilars are biological products similar to but not identical to the original biological agent or "reference biologic," also called "originator biologic." It is hoped that the use of biosimilars might enable these agents to become more available and, thus, decrease further expenditures related to the use of the original reference agents such as infliximab and adalimumab. In this study, we review the currently available evidence and shortcomings of these data supporting the use of biosimilars for the treatment of patients with inflammatory bowel disease, including their efficacy and safety as related to initiating therapy with biosimilar agents or switching between reference and biosimilar biologic agents.
Topics: Adalimumab; Biosimilar Pharmaceuticals; Drug Costs; Drug Substitution; Health Expenditures; Health Services Accessibility; Humans; Inflammatory Bowel Diseases; Infliximab; Tumor Necrosis Factor Inhibitors
PubMed: 33110013
DOI: 10.14309/ajg.0000000000000844 -
The American Journal of Managed Care Feb 2023AbbVie's adalimumab (Humira) is the top-selling pharmaceutical in the world. Due to concerns about government health program spending on Humira, the US House Committee... (Review)
Review
AbbVie's adalimumab (Humira) is the top-selling pharmaceutical in the world. Due to concerns about government health program spending on Humira, the US House Committee on Oversight and Accountability opened an investigation in 2019 to investigate AbbVie's pricing and marketing practices. We review these reports and describe policy debates surrounding the highest-grossing drug to highlight how the legal landscape enables incumbent manufacturers to block competition in the pharmaceutical market. Tactics include patent thickets, evergreening, Paragraph IV settlement agreements, product hopping, and linking executive compensation to sales growth. These strategies are not unique to AbbVie and shed light on pharmaceutical market dynamics that may be hindering a competitive market. Policy reform and legal initiatives may help reduce anticompetitive behaviors by pharmaceutical manufacturers and increase access to competitive therapeutic options such as biosimilars.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals; Pharmaceutical Preparations; Drug Costs; Drug Industry
PubMed: 36811981
DOI: 10.37765/ajmc.2023.89315 -
The Journal of Dermatological Treatment Dec 2023We aimed to systematically evaluate the efficacy and safety of adalimumab biosimilar agents in the treatment of moderate-to-severe plaque psoriasis, in order to provide... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
We aimed to systematically evaluate the efficacy and safety of adalimumab biosimilar agents in the treatment of moderate-to-severe plaque psoriasis, in order to provide evidence-based reference data for clinical medicine.
MATERIALS AND METHODS
Five databases were searched by electronic retrieval: PubMed, Embase, Cochrane Library, WanFang and CNKI (China National Knowledge Internet). The retrieval period was from the establishment of each database up to April 2022. Randomized controlled trials (RCTs) on adalimumab biosimilar agents compared with their reference agents in the treatment of moderate-to-serve plague psoriasis were included. A meta-analysis using RevMan software was applied to 8 RCTs involving 2589 patients.
RESULTS
After 16 weeks of medication, there was no significant difference in the response rates of adalimumab biosimilar agents and their reference agents defined as a decrease in the Psoriasis Area and Severity Index (PASI) of ≥75% (PASI 75) ( > 0.05), or in the PASI 50, PASI 90 and PASI 100 measures ( > 0.05). After 16 weeks and 24 weeks of medication, there was no significant difference in the incidence rate of serious adverse events (SAEs) between adalimumab biosimilar agents and their reference agents ( > 0.05). After 16 weeks, 24 weeks and 51 weeks of medication, there was no significant difference in withdrawal rate due to SAEs, treatment-emergent adverse events and adverse events of special interest between adalimumab biosimilar agents and their reference agents ( > 0.05).
CONCLUSION
These findings suggest that biosimilar agents of adalimumab have an overall efficacy and safety profile for psoriasis comparable to those of their reference agents.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals; China; Databases, Factual; Psoriasis
PubMed: 37608703
DOI: 10.1080/09546634.2023.2249145 -
BMJ Open Ophthalmology Jan 2023To facilitate the integration of eye care into universal health coverage, the WHO is developing a Package of Eye Care Interventions (PECI). Development of the PECI... (Review)
Review
To facilitate the integration of eye care into universal health coverage, the WHO is developing a Package of Eye Care Interventions (PECI). Development of the PECI involves the identification of evidence-based interventions from relevant clinical practice guidelines (CPGs) for uveitis.A systematic review of CPGs published on uveitis between 2010 and March 2020 was conducted. CPGs passing title and abstract and full-text screening were evaluated using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool and data on recommended interventions extracted using a standard data extraction sheet.Of 56 CPGs identified as potentially relevant from the systematic literature search, 3 CPGs underwent data extraction following the screening stages and appraisal with the AGREE II tool. These CPGs covered screening for, monitoring and treating juvenile idiopathic arthritis (JIA)-associated uveitis, the use of adalimumab and dexamethasone in treating non-infectious uveitis, and a top-level summary of assessment, differential diagnosis and referral recommendations for uveitis, aimed at primary care practitioners. Many of the recommendations were based on expert opinion, though some incorporated clinical study and randomised controlled trial data.There is currently sparse coverage of the spectrum of disease caused by uveitis within CPGs. This may partially be due to the large number of conditions with diverse causes and clinical presentations covered by the umbrella term uveitis, which makes numerous sets of guidelines necessary. The limited pool of CPGs to select from has implications for clinicians seeking guidance on clinical care strategies for uveitis.
Topics: Humans; Uveitis; Adalimumab; Arthritis, Juvenile
PubMed: 37278434
DOI: 10.1136/bmjophth-2022-001091 -
Romanian Journal of Ophthalmology 2018Non-infectious uveitis has been long controlled with the use of corticosteroids with many side effects and poor control in some cases. The purpose of this paper was to... (Review)
Review
PURPOSE
Non-infectious uveitis has been long controlled with the use of corticosteroids with many side effects and poor control in some cases. The purpose of this paper was to assess the different biologic agents (in this case infliximab and adalimumab) and to compare their efficacy in the treatment of uveitis.
RESULTS
Adalimumab has been proven very successful in replacing or aiding corticosteroid therapy in different autoimmune mediated uveitis (Juvenile Idiopathic Arthritis, Rheumatoid arthritis, sarcoidosis) whereas infliximab has been used intravenously and recently intravitreally with very promising results in controlling Behcet's related uveitis.
CONCLUSION
Biologic Response Modifiers represent the future of therapy in immune-mediated uveitis. AU = Anterior Uveitis, BCVA = Best Corrected Visual Acuity, BRM = Biologic Response Modifiers, CME = Cystoid Macular Oedema, CPR = C Protein Reactive, ESR = Erythrocyte Sediment Rate, HSV = Herpes Simplex Virus, ICAM = Intercellular Adhesion Molecules, IMT = Immunomodulatory Therapy, JIA = Juvenile Idiopathic Arthritis, MMP = Matrix Metalloproteinases, MTX = Methotrexate, RA = Rheumatoid Arthritis, TB = Tuberculosis, VCAM = Vascular Adhesion Molecules.
Topics: Adalimumab; Arthritis, Juvenile; Biological Therapy; Humans; Macular Edema; Treatment Outcome; Uveitis
PubMed: 30206553
DOI: No ID Found -
Annales de Dermatologie Et de... 2019
Topics: Adalimumab; Anti-Inflammatory Agents; Contraindications, Drug; Drug Monitoring; Humans; Psoriasis
PubMed: 31202514
DOI: 10.1016/j.annder.2019.04.012