- |||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Switching to an Infliximab Biosimilar Was Safe and Effective in Dutch Sarcoidosis Patients. (Pubmed Central) - Oct 22, 2021 An improvement in physical functioning of 7.3 ± 13.4 points (p = 0.002) with RAND/SF36 and in biomarker sIL-2R (-475.58 ± 1452.39; p = 0.005) was observed. Switching from originator infliximab Remicade or biosimilar infliximab Inflectra to biosimilar infliximab Flixabi did not result in treatment discontinuation or loss of clinical/functional/inflammatory remission.
- |||||||||| Journal: Ozanimod (Zeposia) for ulcerative colitis. (Pubmed Central) - Oct 7, 2021
Conclusion Against the background of a finite healthcare budget, this study shows that increasing use of biosimilars can create the financial savings and space to invest in new innovative therapies for the benefit of many patients. No abstract available
- |||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Infusion-related angioedema associated with infliximab-abda: Case report. (Pubmed Central) - Oct 1, 2021 Discontinuation of the biosimilar product along with supportive care brought about resolution of angioedema. There are no prior published reports of infusion-related angioedema reactions secondary to infliximab-abda use.
- |||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Reimbursement, Journal, Medicare: Biosimilar formulary placement in Medicare Part D prescription drug plans: A case study of infliximab. (Pubmed Central) - Oct 1, 2021 Formulary placement of infliximab biologic and biosimilars in Medicare Part D is not optimized to generate cost savings for the Medicare program and beneficiaries, whose cost sharing is often based on the drug's list price. The Medicare program should provide incentives for PDPs to expand biosimilar coverage.
- |||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Retrospective data, Journal: Network meta-analysis of infliximab biosimilars for the treatment of rheumatoid arthritis. (Pubmed Central) - Oct 1, 2021 ACR20 response appears to be comparable and nonsignificantly different between infliximab biosimilars. In the absence of any meaningful differences in safety or efficacy, biosimilar cost may be the deciding factor in choosing a treatment or agent for formulary inclusion.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Similar But Not Identical: Plaque Psoriasis Exacerbation in a Patient With Crohn's Disease After Switching From CT-P13 to SB2 Infliximab Biosimilar. (Pubmed Central) - Sep 24, 2021 In the absence of any meaningful differences in safety or efficacy, biosimilar cost may be the deciding factor in choosing a treatment or agent for formulary inclusion. No abstract available
- |||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
New trial, Real-world evidence, Real-world: SWEFOT-RWEM: Real-World Emulation of the SWEFOT Trial (clinicaltrials.gov) - Sep 21, 2021 P=N/A, N=509, Completed,
- |||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Payor-Mandated Non-Medical Switching From Infliximab to Biosimilar Creates Dosing Delays (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_2811; Sixty-two (8%) patients underwent a payor-mandated non-medical switch to biosimilar (59 infliximab-axxq, 2 infliximab-abda, 1 infliximab-dyyb). Dose and frequency remained the same as originator infliximab for all but one patient whose frequency was increased following bowel resection surgery.
- |||||||||| Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
New P2 trial, Adverse events, Combination therapy, Metastases: PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - Sep 5, 2021 P2, N=36, Not yet recruiting,
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Enrollment closed: PERFUSE: One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study (clinicaltrials.gov) - Aug 9, 2021 P=N/A, N=2274, Active, not recruiting, No abstract available Recruiting --> Active, not recruiting
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Safety and efficacy of switching from infliximab biosimilar CT-P13 to infliximab biosimilar SB2 in patients with inflammatory bowel disease. (Pubmed Central) - Aug 4, 2021 Recruiting --> Active, not recruiting Switching from CT-P13 to SB2 seems to be safe and effective either in patients with a single than in those with multiple switches.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Journal: Statistical Equivalence Testing of Higher-Order Protein Structures with Differential Hydrogen Exchange-Mass Spectrometry (HX-MS). (Pubmed Central) - Jun 30, 2021 Application of the TOST-MDTE test on differential HX-MS measurements of wild-type and mutated maltose-binding proteins demonstrates that the equivalence testing method was fit-for-purpose. Three infliximab biosimilars (Remsima, Renflexis, and Inflectra) were found to be equivalent to their Remicade reference product based on differential HX-MS measurements, while 5% deglycosylated NIST mAb was not statistically equivalent to the unmodified NIST mAb reference.
- |||||||||| Imraldi (adalimumab biosimilar) / Biogen, Merck (MSD), Samsung, Mundipharma
Clinical, Journal: Radiographic progression based on baseline characteristics from TNF inhibitor biosimilar studies in patients with rheumatoid arthritis. (Pubmed Central) - Jun 22, 2021 P3 In this pooled analysis of phase III clinical trial data of biosimilars for RA, identifiable baseline factors (SJC28, CRP, and PhGA) associated with radiographic progression were similar to those described in prior studies. Even though radiographic progression was minimal, a small number of patients who have increased SJC28, CRP, and PhGA at baseline should be closely monitored and follow treat-to-target approach.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen, Mundipharma
Clinical, Journal: Identification of QTLs for Spot Blotch Resistance in Two Bi-Parental Mapping Populations of Wheat. (Pubmed Central) - Jun 3, 2021 The identified QTLs upon stacking showed an additive effect in lowering the SB score in both populations. The probable presence of newly identified Sb4 and durable resistance gene Lr46 in the identified QTL regions indicates the importance of these genes in breeding for SB resistance in Bangladesh and the whole of South Asia.
- |||||||||| 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.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Switching from one infliximab biosimilar (CT-P13) to another infliximab biosimilar (SB2) in patients with chronic plaque psoriasis. (Pubmed Central) - May 15, 2021 CT-P13 and SB2 are two distinct biosimilars of the reference originator anti-tumour necrosis factor alpha monoclonal antibody infliximab. Real-life evidence has shown that the switch from infliximab originator to CT-P13 did not impair overall clinical efficacy and safety in patients with Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis and chronic plaque psoriasis.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen, Mundipharma
Clinical, Journal, Real-world evidence: Real World SB4 (Etanercept Biosimilar) Use in Patients With Psoriasis: Data from the British Association of Dermatologists Biologic Interventions Register (BADBIR). (Pubmed Central) - May 4, 2021 Real-life evidence has shown that the switch from infliximab originator to CT-P13 did not impair overall clinical efficacy and safety in patients with Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis and chronic plaque psoriasis. Psoriasis is a chronic, systemic, inflammatory skin disease with a risk of comorbidities and a potential high impact on patients’ quality of life.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Outcomes after double switching from originator Infliximab to biosimilar CT-P13 and biosimilar SB2 in patients with inflammatory bowel disease: a 12-month prospective cohort study. (Pubmed Central) - Apr 20, 2021 A pooled analysis of radiographic assessment data from three biosimilar studies showed that radiographic progression is small overall but increases with worse disease activity. Double switching from the originator Infliximab to CT-P13 and then to SB2 was not associated with an impairment in patient beliefs, while the effectiveness, immunogeniity and safety of anti-TNF therapy remained stable after 54 weeks of follow-up.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
[VIRTUAL] Comparison of treatment patterns following initiation of Renflexis, Inflectra, or Remicade () - Apr 17, 2021 - Abstract #AMCP2021AMCP_351; Double switching from the originator Infliximab to CT-P13 and then to SB2 was not associated with an impairment in patient beliefs, while the effectiveness, immunogeniity and safety of anti-TNF therapy remained stable after 54 weeks of follow-up. Awaiting results
- |||||||||| Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
[VIRTUAL] Outcomes with Infliximab and Its Biosimilars in Patients with Rheumatoid Arthritis (RA)- Real-World Experience in the US () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_80; In LR variables significantly associated the outcome were baseline disease activity (high/moderate vs low/remission: adjusted odds ratio (OR)=.09 CI .07-.14), payer type (Medicaid vs commercial: OR=.47 CI=.22-.99, and use of steroids (OR=.56 CI .40-.79) but not choice of a biologic (infliximab-abda vs infliximab OR=.91 CI .49-1.69, infliximab-dyyb vs infliximab OR=1.11 CI .74-1.65). CONCLUSIONS After accounting for patient characteristics, regimen choice was not significantly associated with treatment success at 6 months since regimen initiation.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen, Mundipharma
Journal: Air quality measurements in four sheep barns part II: pollutant gas emissions. (Pubmed Central) - Apr 10, 2021 The average NH and CH emissions from each barn were 2.1 and 2.7 kg day barn for SB1; 9.4 and 12.9 kg day barn for SB2; 4.0 and 3.6 kg day barn for SB3; and 4.5 21 kg day barn for SB4, respectively...These models can only be used in the Bursa region. The results of this study were compared with other studies under similar conditions in the literature.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen, Mundipharma
Retrospective data, Journal: Etanercept biosimilar SB4 in the treatment of plaque-type psoriasis and psoriatic arthritis: a single-center, observational, retrospective, real-life study. (Pubmed Central) - Mar 16, 2021 Being the development of biosimilars a significant opportunity to decrease medical care cost and increase treatment options (3), extrapolation of clinical data from other indications determined an intense scientific debate on the interchangeability between originator and biosimilar in real-life, and recently reports on efficacy and safety of the biosimilar SB4 in plaque-type psoriasis have been published (4, 5). The aim of our observational, retrospective, single-center, study was to investigate the etanercept biosimilar SB4 in patients affected by plaque-type psoriasis and PsA.
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