- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / AbbVie
Adalimumab-bwwd, a biosimilar of adalimumab, has the potential for substantial cost savings when prescribed () - Apr 9, 2024 - Abstract #AMCP2024AMCP_152;
In a scenario based on publicly available pricing, substantial cost savings were generated from switching patients to adalimumab-bwwd. As confirmed by real-world experience of other biosimilar adoption in the United States, the magnitude of these savings is dif- ficult to predict because of invisible rebate structures but adoption of biosimilars would inevitably realize substan- tial savings to plans.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / AbbVie
Outcome of psoriasis patients switched from adalimumab originator to biosimilar: a retrospective, observational study () - Feb 20, 2024 - Abstract #AAD2024AAD_2896;
Background As a cost saving measure, psoriasis patients established on adalimumab originator (Humira) were switched to adalimumab biosimilar, Imraldi...31 patients were switched back to originator/alternative biosimilar (Amgevita)...Patients who successfully switched back to the originator, did not re-achieve the same disease control as before switching. Factors associated with switching failure included: male sex, higher weight, high-impact sites involvement and presence of concomitant PsA.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / AbbVie
Interchangeability of SB5 and Adalimumab Reference Product in Patients with Moderate to Severe Chronic Plaque Psoriasis () - Feb 20, 2024 - Abstract #AAD2024AAD_2240;
Factors associated with switching failure included: male sex, higher weight, high-impact sites involvement and presence of concomitant PsA. Multiple switches between SB5 and RP have equivalent PK, with comparable efficacy, safety, and immunogenicity to continuation of RP.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Journal: Efficacy and Safety of Switching from Adalimumab Originator to SB5, Adalimumab Biosimilar for Noninfectious Uveitis. (Pubmed Central) - Jan 9, 2024
To evaluate the efficacy and safety of switching from adalimumab originator (Humira, AbbVie) to SB5, adalimumab biosimilar (Adalloce, Samsung Bioepis) in patients with noninfectious uveitis (NIU)...No other adverse events occurred after switching to SB5. Switching from adalimumab originator to SB5 for NIU does not result in clinically significant differences in treatment efficacy and safety.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Review, Journal: Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases. (Pubmed Central) - Dec 19, 2023
In post-approval studies, the quality of SB5 was consistent over time, independent of the batch and process changes, and the SB5 autoinjector was preferred over other autoinjectors by both healthcare professionals and patients. Taken together, these data support the use of SB5 whenever reference adalimumab is appropriate and demonstrate that switching from reference adalimumab to SB5 is feasible.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Hukyndra (adalimumab biosimilar) / Cipla, Alvotech, Stada, Teva, JAMP Pharma, YAS Holding, Yuflyma (adalimumab-aaty) / Celltrion, Hikma
Review, Journal: Navigating adalimumab biosimilars: an expert opinion. (Pubmed Central) - Nov 3, 2023
Taken together, these data support the use of SB5 whenever reference adalimumab is appropriate and demonstrate that switching from reference adalimumab to SB5 is feasible. 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
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Hyrimoz (adalimumab-adaz) / Novartis, Humira (adalimumab) / AbbVie
Drug survival of patients with psoriasis, who underwent a non-medical mandatory switch from Adalimumab originator to either of the two biosimilar biologics Adalimumab SB5/GP2017 with a year follow-up period using a nationwide cohort study. (e-Poster Hall) - Aug 30, 2023 - Abstract #EADV2023EADV_2780;
Following a non-medical mandatory switch from adalimumab originator to the biosimilar GP2017 and SB5, no differences were found in drug effectiveness. Additionally, no differences in drug survival were observed when comparing the originator cohort with the two biosimilars GP2017 and SB5 cohorts.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma
Review: Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review. (Pubmed Central) - Aug 24, 2023
Therefore, they were preferred over the other reference product autoinjectors. Because user-friendly devices can improve treatment adherence, pharmaceutical companies should consider patient convenience when developing medical devices.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Trial completion: Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - May 25, 2023
P4, N=371, Completed,
This BADBIR data indicates that SB5 can be successfully started or transitioned to from reference adalimumab in patients with moderate-to-severe psoriasis. Active, not recruiting --> Completed
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Observational data, Journal: Effectiveness of non-medical switch from adalimumab bio-originator to SB5 biosimilar and from ABP501 adalimumab biosimilar to SB5 biosimilar in patients with chronic inflammatory arthropathies: a monocentric observational study. (Pubmed Central) - Mar 28, 2023
Our results provide a reassuring profile of effectiveness when switching from ADA originator to one of its biosimilars and between two different biosimilars. However, the worse outcome in PROs in patients initially treated with the bio-originator addresses the attention to a possible nocebo response, which should encourage comprehensive communication with patients.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Journal: Consistency of Product Quality for SB5, an Adalimumab Biosimilar. (Pubmed Central) - Mar 2, 2023
However, the worse outcome in PROs in patients initially treated with the bio-originator addresses the attention to a possible nocebo response, which should encourage comprehensive communication with patients. The data presented in this study provide evidence that the quality of SB5 has remained consistent and tightly controlled even through process changes such as manufacturing site transfers and change in formulation.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / Eisai, AbbVie
A Pan-European Real-World Study of SB5 biosimilar following transition from reference adalimumab: The PROPER study; 48-week analysis of persistence (Poster exhibition) - Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_1230;
A limitation of this finding is the low proportion of subjects discontinuing SB5 prior to Week 48, hence a low incidence of potential candidate predictors. When anticipating persistence, results suggest no evidence to mitigate against transition, within the baseline categories explored.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Enrollment closed, Trial completion date, Trial primary completion date: Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - Nov 1, 2022
P4, N=366, Active, not recruiting,
When anticipating persistence, results suggest no evidence to mitigate against transition, within the baseline categories explored. Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> May 2023 | Trial primary completion date: Aug 2023 --> Apr 2023
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Trial completion: PERFUSE: One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study (clinicaltrials.gov) - Oct 18, 2022
P=N/A, N=2274, Completed,
Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> May 2023 | Trial primary completion date: Aug 2023 --> Apr 2023 Active, not recruiting --> Completed
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
Adalimumab originator versus biosimilar adalimumab () - Oct 4, 2022 - Abstract #AGW2022AGW_465;
Familiarity with these factors is imperative to allow individualized prescribing so that the choice of agent can be individualized to the needs of the patient, prescriber, and health care service. Targeted prescribing according to patients' needs may improve adherence, treatment success, and quality of life.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden. (Pubmed Central) - Sep 10, 2022
A limitation of this finding is the relatively low proportion of subjects discontinuing SB5 prior to Week 48, hence a low incidence of potential candidate predictors within the dataset; p-values should be interpreted with caution. This large observational study supports the equivalence of biologic DMARD biosimilar products and originators when used in routine rheumatology care.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
New P4 trial: Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - Aug 22, 2022
P4, N=366, Recruiting,
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
THERAPEUTIC DRUG MONITORING: STANDARDIZATION OF PROMONITOR QUICK IFX AND PROMONITOR QUICK ADL POINT OF CARE TESTS WITH WHO INTERNATIONAL STANDARDS FOR THE QUANTIFICATION OF INFLIXIMAB AND ADALIMUMAB IN WHOLE BLOOD AND SERUM (Science Lounge) - Jul 20, 2022 - Abstract #UEGW2022UEGW_1801;
Both tests can quantify reference and biosimilar drugs with equivalent results. Moreover, comparable results were obtained with the WHO IS, and thus, demonstrate that Promonitor Quick tests are suited to accurately determine drug levels at the clinical decision points in both whole blood and serum, proving to be an effective and valuable tool in TDM and immediate decision making in the doctor office or hospitals.
- |||||||||| Hadlima (adalimumab biosimilar) / Organon, Merck (MSD), Biogen, Samsung, Mundipharma
PK/PD data, Journal: A Randomized Pharmacokinetic Study in Healthy Male Subjects Comparing a High-concentration, Citrate-free SB5 Formulation (40 mg/0.4 ml) and Prior SB5 (Adalimumab Biosimilar). (Pubmed Central) - Jul 2, 2022
P1
Moreover, comparable results were obtained with the WHO IS, and thus, demonstrate that Promonitor Quick tests are suited to accurately determine drug levels at the clinical decision points in both whole blood and serum, proving to be an effective and valuable tool in TDM and immediate decision making in the doctor office or hospitals. This bridging study demonstrated PK equivalence and comparable safety and tolerability of subcutaneous injection of SB5 via SB5-HC or SB5-LC.
- |||||||||| Hadlima (adalimumab biosimilar) / Organon, Merck (MSD), Biogen, Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
THERAPEUTIC DRUG MONITORING: STANDARDIZATION OF PROMONITOR QUICK IFX AND PROMONITOR QUICK ADL POINT OF CARE TESTS WITH WHO INTERNATIONAL STANDARDS FOR THE QUANTIFICATION OF INFLIXIMAB AND ADALIMUMAB IN WHOLE BLOOD AND SERUM () - May 24, 2022 - Abstract #EULAR2022EULAR_3320;
Both tests can quantify reference and biosimilar drugs with equivalent results. Moreover, comparable results were obtained with the WHO IS, and thus, demonstrate that Promonitor Quick tests are suited to accurately determine drug levels at the clinical decision points in both whole blood and serum, proving to be an effective and valuable tool in TDM and immediate decision making in the doctor office or hospitals.
- |||||||||| Hadlima (adalimumab biosimilar) / Organon, Merck (MSD), Biogen, Samsung, Mundipharma
Journal: Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis. (Pubmed Central) - Apr 28, 2022
This real-life study confirms the similar efficacy profile of multiple switch bsADA with long-term retention and a good safety profile in inflammatory arthritis patients. The real-life effectiveness of adalimumab biosimilars in patients with psoriasis is consistent with that previously reported for the originator.
- |||||||||| Hadlima (adalimumab biosimilar) / Organon, Merck (MSD), Biogen, Samsung, Mundipharma, Humira (adalimumab) / Eisai, AbbVie
A Randomised Phase I Pharmacokinetic Study Comparing High-concentration, Low-volume, and Citrate-free SB5 (40 mg/0.4 mL) with Prior SB5 Formulation, and Adalimumab Biosimilar, in Healthy Male Subjects (Poster View 3) - Apr 21, 2022 - Abstract #EULAR2022EULAR_1631;
This study demonstrated PK equivalence between SB5-HC and SB5-LC in healthy subjects. Both SB5-HC and SB5-LC were generally well tolerated with similar safety profiles.
- |||||||||| Hadlima (adalimumab biosimilar) / Biogen, Samsung, Mundipharma, Organon
Journal: Current evidence on the use of the adalimumab biosimilar SB5 (Imraldi): a multidisciplinary perspective. (Pubmed Central) - Apr 7, 2022
Evidence derived from clinical studies suggest that the biosimilar SB5 is a safe and effective alternative to reference adalimumab. Considering that patients suffering from immune-mediated inflammatory diseases such as inflammatory arthritis, inflammatory bowel disease and psoriasis often require long-term biologic treatment, biosimilar medicines (such as SB5) can reduce healthcare costs while increasing access to effective treatments.
- |||||||||| Hadlima (adalimumab biosimilar) / Biogen, Samsung, Mundipharma, Organon
Journal: A Patients' Perspective Towards the Injection Devices for Humira® and Imraldi® in a Nationwide Switching Program. (Pubmed Central) - Feb 15, 2022
After all, these injection devices' structure and content are not the same, although both contain the same active ingredient, i.e. adalimumab. Our results highlight the importance of thorough information, not only with an information letter but also with the possibilities for individualized introduction in planning switching to biosimilars.
- |||||||||| Trial completion, Real-world evidence, Real-world: PROPER: A Real-world Study of Imraldi (clinicaltrials.gov) - Jan 13, 2022
P=N/A, N=1000, Completed,
No abstract available Active, not recruiting --> Completed
- |||||||||| Hadlima (adalimumab biosimilar) / Biogen, Samsung, Mundipharma, Organon, Humira (adalimumab) / Eisai, AbbVie
Therapeutic drug monitoring: standardization of Promonitor Quick IFX and Promonitor Quick ADL point of care tests with WHO International Standards for the quantification of infliximab and adalimumab in whole blood and serum (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_1058;
Promonitor Quick ADL was evaluated using the reference drug, ABP501 and SB5 biosimilars, and the WHO IS (NIBSC 17/236)...Both tests can quantify reference and biosimilar drugs with equivalent results. Moreover, comparable results were obtained with the WHO IS, and thus, demonstrate that Promonitor Quick tests are suited to accurately determine drug levels at the clinical decision points in both whole blood and serum, proving to be an effective and valuable tool in TDM and immediate decision making in the doctor office or hospitals.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo, Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma
📰Adalimumab biosimilars, ABP501 (Amjevita®️) and SB5 (Imraldi®️), are equally effective and safe as original adalimumab ✅ Not surprising, but Good news! 👌🏽 @bribarberio @AmgenSpain @AmgenBiosim @biogen @nature @SciReports #medtwitter #IBD #GITwitter #IBDTwitter #livertwitter (Twitter) - Dec 15, 2021
- |||||||||| Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma, Halimatoz (adalimumab biosimilar) / Novartis
Clinical, Observational data, Journal, HEOR, Real-world evidence: Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial. (Pubmed Central) - Nov 24, 2021
This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.
- |||||||||| Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma
[VIRTUAL] The comorbidome of sarcoidosis () - Nov 10, 2021 - Abstract #BTSWMI2021BTS_WM_I_414;
4% of patients are prescribed Imraldi...Conclusion The pattern and impact of comorbidities give significant insights to treatment phenotypes of sarcoid patients attending clinic and inform treatment choices. This granular approach lends itself to Precision Medicine allowing the customization of healthcare being tailored to a subgroup of patients, instead of a one drug fits all approach.
- |||||||||| Yuflyma (adalimumab biosimilar) / Pfizer, Celltrion, Nippon Kayaku
Journal: Investigation of the Physicochemical and Biological Stability of the Adalimumab Biosimilar CT-P17. (Pubmed Central) - Nov 10, 2021
Our data suggest that CT-P17 may be used without any significant loss of stability when stored at 5 °C or 25 °C with 60% relative humidity for up to 28 days, and was not impacted by protein concentration tested and delivery device. Comparative stability data suggest that the appropriate maximum storage period for CT-P17 may be up to 28 days at room temperature with 60% relative humidity.
|
