- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
New P3 trial: A Comparative Study Between ABP 501 and Humira (clinicaltrials.gov) - Oct 10, 2021 P3, N=414, Not yet recruiting,
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo, Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma
Clinical, Journal: Switching from Biosimilar to Biosimilar Adalimumab, Including Multiple Switching, in Crohn's Disease: A Prospective Study. (Pubmed Central) - Aug 8, 2021 We conducted a prospective, single-centre observational study in which we consecutively recruited all CD patients who switched from adalimumab biosimilar ABP 501 to biosimilar SB5 from January to July 2021...Seven patients (11.5%) experienced side effects, compared to one patient (1.6%) in the 6 pre-switch months (p = 0.03). In conclusion, switching from biosimilar to biosimilar of adalimumab did not lead to signs of safety or loss of efficacy other than those already known in the literature for the class of drugs.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Clinical, Observational data, Journal: Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn's disease: an observational study. (Pubmed Central) - Jun 30, 2021 This could lead to a more rapid and effective optimization of the biological drug, thus avoiding treatment failure. our results support ABP 501 as an effective and well-tolerated drug, with a good interchangeability with its originator for the treatment of Crohn's disease.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab biosimilar) / Amgen, Daiichi Sankyo
Clinical, Journal: Effectiveness and safety of switching to adalimumab biosimilar ABP 501 in Crohn's disease. (Pubmed Central) - Jun 8, 2021 (Rev Esp Enferm Dig 2020; 112: 195-200)" demonstrate that the adalimumab biosimilar ABP 501 can determine the clinical benefit with a satisfactory safety profile until the end of follow-up in a group of patients with Crohn's disease. This result could have important practical implications as it supports the concept that a biosimilar -after the approval by the European Medicines Agency- is considered interchangeable with its originator.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie
[VIRTUAL] A SURVEY OF RHEUMATOLOGY PATIENTS’ SATISFACTION TO SWITCHING FROM ORIGINATOR TO BIOSIMILAR AGENTS () - May 21, 2021 - Abstract #EULAR2021EULAR_3790; Only 28% of the patients found the new device difficult to use. Overall conclusion from the study showed less than one quarter of the participants showed dissatifaction towards biosimilar and less than 12 % experienced systemic side effects and whether biosimilar could be a next cost effective biologic therapy to replace originator in future requires a longer duration of study.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] DIFFERENCES IN DRUG SURVIVAL BETWEEN ORIGINATOR AND BIOSIMILAR PRODUCTS AMONG FIRST USERS OF EACH MOLECULE (Posters Viewing) - May 21, 2021 - Abstract #EULAR2021EULAR_2066; Despite their identical indications and therapeutic positioning, there are some differences in the baseline characteristics between patients who start ADA, IFX and RIT and their biosimilars. There are no differences in drug survival between originator and biosimilar with the possible exception of etanercept although the observed difference should be interpreted in light of possible unmeasured or residual channeling.
- |||||||||| Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Head-to-Head: ADA-SWITCH: Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. (clinicaltrials.gov) - Jan 12, 2021 P4, N=24, Terminated, Not yet recruiting --> Recruiting N=216 --> 24 | Trial completion date: Jan 2021 --> Jun 2020 | Not yet recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Jun 2020; Sponsor cancellation
- |||||||||| Review, Journal: Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. (Pubmed Central) - Dec 3, 2020
P1, P3 Data from several switching studies showed no changes in efficacy, safety, trough serum drug concentration, or immunogenicity between the biosimilars and their RP.Trial registration: ClinicalTrials.gov identifiers: NCT02260791, NCT02405780, NCT01970475, NCT02137226, NCT02045979, NCT02744755, NCT02144714, NCT02167139, NCT03014947, NCT02114931, NCT02640612, NCT02640612, NCT02167139, NCT03052322, NCT02480153. EudraCT numbers: 2012-005140-23, 2012-000785-37, 2013-003722-84, 2015-000579-28, 2014-002879-29, 2014-000662-21, 2013-004654-13, 2015-002634-41, 2014-005229-11, 2016-002852-26, 2014-000352-29.
- |||||||||| [VIRTUAL] The Biosimilar Effect on Adalimumab Originator Price- The Italian Scenario () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1825;
Our analysis shows the relevance of biosimilars from a market price perspective. While for adalimumab originator AIFA price negotiations (additional therapeutic indications) only had a limited effect, the introduction of biosimilars, due to a competitive effect, has significantly reduced the overall net price of both originator and biosimilars, with understandable benefit for iNHS spending.
- |||||||||| 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_4606; 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.
- |||||||||| 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_2630; 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.
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