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11 Diseases |  |
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10 Trials |  |
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- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
[VIRTUAL] REAL-LIFE EFFECTIVENESS AND SAFETY OF ABP501, AN ADALIMUMAB BIOSIMILAR, IN INFLAMMATORY BOWEL DISEASE: A MULTICENTER ITALIAN STUDY (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_657;
This abstract will be published on October 11, 2020
- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
[VIRTUAL] SWITCHING FROM ADALIMUMAB ORIGINATOR TO ABP 501 BIOSIMILAR: A MULTICENTRIC NORTH ITALIAN STUDY (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_646;
Our data shows that after switching, 1/3 of the patients may experience a disease relapse, requiring treatment optimization (i.e. addiction of steroids or increasing the dose to once a week) or treatment discontinuation. Thus, patients should be strictly observed in order to prevent or, at least, early manage such clinical relapses.
- | New trial: Rhoneswitch: A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira (clinicaltrials.gov) - Jun 8, 2020
P, N=400, Not yet recruiting, Sponsor: University Hospital, Grenoble
- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
[VIRTUAL] RETENTION RATE OF ADALIMUMAB AND ABP 501 IN THE TREATMENT OF A LARGE COHORT OF PATIENTS WITH INFLAMMATORY ARTHRITIS: A REAL LIFE RETROSPECTIVE ANALYSIS (Poster View) - May 22, 2020 - Abstract #EULAR2020EULAR_3188;
In our retrospective study adalimumab originator and its biosimilar ABP 501 showed the same effectiveness. Patients switching from originator to biosimilar showed an higher retention rate when compared to naive.
- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
[VIRTUAL] REAL-WORLD EXPERIENCE ON SWITCHING ADALIMUMAB ORIGINATOR TO BIOSIMILAR IN INFLAMMATORY ARTHRITIS – A RETROSPECTIVE STUDY () - May 22, 2020 - Abstract #EULAR2020EULAR_2575;
The adalimumab biosimilar has been generally well-tolerated. 93% remained on biosimilar 24 weeks after switching, 4% have switched back to originator and 3% have either stopped or changed treatment.
- [VIRTUAL] DEMYELINATING DISEASE AFTER EXPOSURE TO TUMOR NECROSIS FACTOR ALPHA INHIBITORS (TNFI): LONG-TERM OUTCOMES FROM A SINGLE CENTER () - May 22, 2020 - Abstract #EULAR2020EULAR_1352;
Presentations included both central and peripheral demyelinating events. With the exception of one patient who developed MS, withdrawal of TNFi’s appeared to halt further progression or development of new neurologic symptoms.
- Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie
[VIRTUAL] Acute hypersensitivity reaction to infliximab followed by a delayed cutaneous reaction to adalimumab: A challenging case () - May 19, 2020 - Abstract #EAACI2020EAACI_2072;
Nevertheless, delayed cutaneous reactions to ADA at the injection sites have been rarely reported. We present a delayed reaction to ADA at the 4 initial injection sites with histopathology consistent with an inflammatory reaction but which was difficult to reproduce on further testing and rechallenge with Amgevita or its excipients and the antiseptics.
- | Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Review, Journal: A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501. (Pubmed Central) - May 19, 2020
The pivotal phase 3 study in patients with RA also established clinical similarity between ABP 501 and adalimumab RP; an open-label extension of this study demonstrated sustained efficacy over an additional 72 weeks, with no new safety or immunogenicity concerns with ABP 501 treatment. Overall, the TOE supported the conclusion that ABP 501 is highly similar to adalimumab RP and provided scientific justification for extrapolation to all the approved indications of adalimumab RP not protected by exclusivities.Funding: Amgen Inc.
- | New trial: NeuMRA: Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients (clinicaltrials.gov) - May 6, 2020
P=N/A, N=212, Not yet recruiting, Sponsor: Vastra Gotaland Region
- Humira (adalimumab) / Eisai, AbbVie
DEVELOPMENT AND EVALUATION OF I-TRACKER ADALIMUMAB AND I-TRACKER ANTI-ADALIMUMAB KITS: FAST INNOVATIVE CHEMILUMINESCENT ASSAYS FOR THE MONITORING OF PATIENTS TREATED WITH ADALIMUMAB () - May 4, 2020 - Abstract #DDW2020DDW_6464;
Excellent agreements were observed with respective LISA-TRACKER assays. i-TRACKER kits are valuable tools for the monitoring of patients treated with Adalimumab
- || Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Clinical, Journal: An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis. (Pubmed Central) - Apr 10, 2020
P3
Long-term safety, immunogenicity, and efficacy were similar in the ABP 501/ABP 501 and RP/ABP 501 groups. The single switch from RP to ABP 501 did not impact immunogenicity.
- | Journal: Biosimilars of adalimumab: the upcoming challenge in IBD. (Pubmed Central) - Apr 1, 2020
Expert opinion Biosimilars of adalimumab appear to be clinically equivalent to the RP. Decisions based on choosing the ideal patient to receive or to be switched to a biosimilar of adalimumab, or choosing one biosimilar vs. another, or cross-switching among biosimilars remain the next challenge in the field of IBD.
- ||| Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
I'm on Amgevita a humira biosimilar, injected yesterday. Have symptoms of corona, sore throat, dry cough and choke feeling, I'm keeping still, warm and quiet & ok. No fever. I also strongly believe I had this same flu over Xmas. No mucus, no sinus pain, just breathing & aches. (Twitter) - Mar 18, 2020
- || Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo, azathioprine orodispersible / Generic mfg.
Thanks for sharing. Sensible reasoning and as someone on both Azathioprine and Amgevita, it’s interesting to read what my right level of concern should be. (Twitter) - Mar 9, 2020
- || Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Perhaps @Amgen could comment about #Amgevita and #CoronaVirusUpdates (Twitter) - Feb 27, 2020
- | Journal: Biosimilars of adalimumab in IBD: are we ready for that? (Pubmed Central) - Feb 16, 2020
Expert opinion: Biosimilars of adalimumab showed equivalent clinical efficacy to the RP in other immune-mediated diseases. However, defining the ideal patient's profile to receive or to be switched to a biosimilar, choosing one biosimilar vs. another, or cross-switching among biosimilars, will become the next challenge in IBD.
- || Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Review, Journal: Safety and Effectiveness of Anti-Tumor Necrosis Factor-Alpha Biosimilar Agents in the Treatment of Psoriasis. (Pubmed Central) - Feb 13, 2020
In general, these biosimilar agents have been shown to have equivalent efficacy, tolerability, and immunogenicity profiles compared to their originators in patients with rheumatologic disease, although studies in patients with psoriasis are fairly limited. Additional switching studies and post-marketing safety analyses are needed to assess the interchangeability of biosimilar agents with their reference products.
- ||| Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Biosimilar launch: Amgen Launches Amgevita (biosimilar, adalimumab) for the Treatment of Inflammatory Diseases in Brazil @AmgenBiosim https://t.co/fgALAkr989 (Twitter) - Feb 3, 2020
- Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
LOW BIOSIMILAR USE IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE IN THE UNITED STATES BETWEEN 2014 AND 2019: A POPULATION-BASED NATIONAL STUDY () - Jan 28, 2020 - Abstract #DDW2020DDW_2665;
The majority of patients on biosimilars (60% each in CD and UC) had been on remicade prior to initiation of biosimilars. We found biosimilar use to be predominant in males and adults.
- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
EFFECTIVENESS AND SAFETY OF ABP501, AN ADALIMUMAB BIOSIMILAR, IN NAÏVE PATIENTS WITH IBD AND IN THOSE UNDERGOING SWITCHING FROM ADALIMUMAB ORIGINATOR: A MULTICENTRIC NORTH ITALIAN STUDY. () - Jan 28, 2020 - Abstract #DDW2020DDW_2066;
After switching, 1/3 of the patients experiences a disease relapse, requiring treatment optimization or treatment discontinuation. Further studies are mandatory to understand the clinical implications of these findings
- Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo, Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma
Validation of two commercial assays for therapeutic drug monitoring of adalimumab biosimilars (Hall C - Poster exhibition) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1604;
Linearity was shown for both AMGEVITA® and Imraldi®.Conclusion We successfully validated the biosimilars AMGEVITA® and Imraldi® in the RIDASCREEN® ADM Monitoring and RIDA®QUICK ADM Monitoring. These results encourage therapeutic drug monitoring of ADM biosimilars in routine clinical practice.
- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Use of adalimumab biosimilar ABP 501 in Crohn’s disease: A real-life experience (Hall C - Poster exhibition) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1523;
No unexpected adverse events occurred during the study period. Conclusion Our results support ABP 501 as an efficacious and well-tolerated drug, at least in the short-term, and its interchangeability with its originator in the treatment of CD.
- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Switching from adalimumab originator to ABP 501 biosimilar: a multicentre North Italian study (Hall C - Poster exhibition) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1378;
Thus, patients should be strictly observed in order to prevent or, at least, early manage such clinical relapses. Larger and longer studies are mandatory to understand the clinical implications of these findings.
- Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Real-life effectiveness and safety of ABP501, an adalimumab biosimilar, in inflammatory bowel disease: a multicentre Italian study (Hall C - Poster exhibition) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1348;
Finally, 7/33 (21.2%) and 5/18 (27.7%) patients needed therapeutic optimisation at T1 and T2, respectively.Conclusion ABP501 seemed to be successful in achieving clinical remission and steroid-free clinical remission, but further data are required. Overall the therapy was well tolerated.
- || Clinical, Review, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents. (Pubmed Central) - Nov 16, 2019
In conclusion, immunogenicity data of biosimilars or biosimilar candidates for TNFα or CD20 inhibitors were collected in trials that varied in design and procedures for ADAb/nAb detection. In general, immunogenicity parameters of biosimilars are similar to those of their reference products.
- | Journal: Drugs for psoriasis. (Pubmed Central) - Nov 13, 2019
In general, immunogenicity parameters of biosimilars are similar to those of their reference products. No abstract available
- | Journal: Expanded table: some drugs for psoriasis. (Pubmed Central) - Nov 13, 2019
No abstract available No abstract available
- | Hulio (adalimumab-fkjp) / Fujifilm Kyowa Kirin Biologics, Biocon, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Hyrimoz (adalimumab-adaz) / Sandoz
New P4 trial, Head-to-Head: Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW) (EUDRACT) - Nov 12, 2019
P4, N=89, Ongoing, Sponsor: Reade
- | Review, Journal: Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis. (Pubmed Central) - Oct 24, 2019
The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety.
- | Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
New P4 trial, Head-to-Head: ADA-SWITCH: Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. (clinicaltrials.gov) - Oct 17, 2019
P4, N=216, Not yet recruiting, Sponsor: Fundaci
- ||| Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Name alert! In Europe it's Amgevita In the US it's Amjevita It's adalimumab. (#Biosimilar to Humira, the blockbuster drug for rheumatoid & psoriatic arthritis &other diseases.) Available in Europe last year. Avail in US in 2023 as adalimumab-atto. https://t.co/PzwOheE3pX (Twitter) - Aug 22, 2019
- || Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Fascinating, incredibly well-written, but worrying read on #biosimilars like #Amgevita from @AmgenBiosim. I hope Amanda and others are listened to by @CNWLNHS and the wider @NHSEngland. #Humira #Consent (Twitter) - Aug 22, 2019
- ||| Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Any #ankylosingspondylitis sufferers taking @Amgen #amgevita and up for answering a couple of questions for a fellow AS sufferer please!? #notsohelpfulhelpline (Twitter) - Aug 19, 2019
- | Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Review, Journal: Biosimilars in dermatology: The wind of change. (Pubmed Central) - Aug 7, 2019
The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world.
- | Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Journal: Scientific and statistical considerations in evaluating the analytical similarity of ABP 501 to adalimumab. (Pubmed Central) - Aug 7, 2019
Statistical considerations are used to establish objective assessment criteria. The result is a scientifically justified, objective analytical similarity assessment that demonstrates that a proposed biosimilar is structurally and functionally similar to a reference product.
- | Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Clinical, P3 data, Journal: Clinical Similarity of the Biosimilar ABPÂ 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients. (Pubmed Central) - Apr 10, 2019
P3
The result is a scientifically justified, objective analytical similarity assessment that demonstrates that a proposed biosimilar is structurally and functionally similar to a reference product. ABP 501 and adalimumab have similar clinical efficacy, safety, and immunogenicity profiles over 52 weeks, including after single transition, in this patient population.
- | Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Journal, HEOR: The effect of new biosimilars in rheumatology and gastroenterology specialities on UK healthcare budgets: Results of a budget impact analysis. (Pubmed Central) - Apr 7, 2019
The introduction of new infliximab, etanercept and adalimumab biosimilars will be associated with considerable cost savings and have a substantial favourable impact on the UK NHS budget. The number of biosimilars and time of entry of is critical to create competition which will result in maximum cost savings.
- ||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Trial completion: OLE Study: Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - Apr 25, 2016
P3, N=467, Completed, Sponsor: Amgen
The number of biosimilars and time of entry of is critical to create competition which will result in maximum cost savings. Active, not recruiting --> Completed
- |||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Trial primary completion date: OLE Study: Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - Feb 4, 2016
P3, N=467, Active, not recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Trial primary completion date: Sep 2016 --> Apr 2016
- ||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Trial completion: Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA (clinicaltrials.gov) - Apr 20, 2015
P3, N=350, Completed, Sponsor: Amgen
Trial primary completion date: Sep 2016 --> Apr 2016 Active, not recruiting --> Completed
- ||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Trial completion, Trial primary completion date: Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - Feb 6, 2015
P3, N=526, Completed, Sponsor: Amgen
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Apr 2015 --> Nov 2014
- ||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Enrollment closed: OLE Study: Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - Jan 15, 2015
P3, N=467, Active, not recruiting, Sponsor: Amgen
Active, not recruiting --> Completed | Trial primary completion date: Apr 2015 --> Nov 2014 Recruiting --> Active, not recruiting
- |||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Trial primary completion date: Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA (clinicaltrials.gov) - Aug 26, 2014
P3, N=350, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Trial primary completion date: Aug 2015 --> Jul 2014
- ||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Enrollment closed: Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - Jun 2, 2014
P3, N=526, Active, not recruiting, Sponsor: Amgen
Trial primary completion date: Aug 2015 --> Jul 2014 Recruiting --> Active, not recruiting
- | Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Trial initiation date: OLE Study: Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - May 1, 2014
P3, N=425, Ongoing, Sponsor: Amgen Inc.
Recruiting --> Active, not recruiting Initiation date: Feb 2014 --> Feb 2014
- ||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Enrollment closed: Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA (clinicaltrials.gov) - Apr 15, 2014
P3, N=350, Active, not recruiting, Sponsor: Amgen
Initiation date: Feb 2014 --> Feb 2014 Recruiting --> Active, not recruiting
- || Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
New P3 trial: OLE Study: Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - Jan 13, 2014
P3, N=425, Ongoing, Sponsor: Amgen Inc.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
New P3 trial: Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA (clinicaltrials.gov) - Oct 24, 2013
P3, N=350, Active, not recruiting, Sponsor: Amgen
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
New P3 trial: Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - Oct 24, 2013
P3, N=500, Recruiting, Sponsor: Amgen