- |||||||||| 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.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal, HEOR: Budget Impact of Sequential Treatment with Biologics, Biosimilars, and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Thai Patients with Rheumatoid Arthritis. (Pubmed Central) - Sep 17, 2021
The order of targeted therapy starting with RTX, then IFX biosimilar, TOF, and finally TCZ incurred the lowest budget impact over a 5-year time horizon for treating moderate to severe RA. Our findings may help payers and policy makers consider appropriate budget allocation on chronic non-communicable diseases, especially RA.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Ixifi (infliximab biosimilar) / Pfizer, Novartis
[VIRTUAL] BOTH SINGLE AND MULTIPLE SWITCHING BETWEEN INFLIXIMAB BIOSIMILARS CAN BE SAFE AND EFFECTIVE IN IBD: REAL WORLD OUTCOMES FROM THE EDINBURGH IBD UNIT (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_4603;
Switching between CT-P13 and Zessly did not affect treatment efficacy, pharmacokinetics and safety. Moreover, this held true in a double switch group originally treated with Remicade.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Ixifi (infliximab biosimilar) / Pfizer, Novartis
[VIRTUAL] BOTH SINGLE AND MULTIPLE SWITCHING BETWEEN INFLIXIMAB BIOSIMILARS CAN BE SAFE AND EFFECTIVE IN IBD: REAL WORLD OUTCOMES FROM THE EDINBURGH IBD UNIT (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_2423;
Switching between CT-P13 and Zessly did not affect treatment efficacy, pharmacokinetics and safety. Moreover, this held true in a double switch group originally treated with Remicade.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Ixifi (infliximab biosimilar) / Pfizer, Novartis
[VIRTUAL] BOTH SINGLE AND MULTIPLE SWITCHING BETWEEN INFLIXIMAB BIOSIMILARS CAN BE SAFE AND EFFECTIVE IN IBD: REAL WORLD OUTCOMES FROM THE EDINBURGH IBD UNIT (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_592;
Switching between CT-P13 and Zessly did not affect treatment efficacy, pharmacokinetics and safety. Moreover, this held true in a double switch group originally treated with Remicade.
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis
Clinical, P3 data, Journal: Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. (Pubmed Central) - Jan 28, 2021
P3
Results to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54.
- |||||||||| Ixifi (infliximab-qbtx) / Pfizer, Novartis, Hyrimoz (adalimumab-adaz) / Novartis
Trial completion, Enrollment change, Trial completion date, Real-world evidence, Real-world: GIANT: Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease (clinicaltrials.gov) - Jan 22, 2021
P=N/A, N=63, Completed,
There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54. Recruiting --> Completed | N=1600 --> 63 | Trial completion date: Jun 2025 --> May 2020
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis
Journal: Biosimilar infliximab administration for the management of acute graft-versus-host disease. (Pubmed Central) - Jan 8, 2021
In these patients with steroid-refractory aGVHD, we were able to show that infliximab biosimilars could be used in lieu of the reference infliximab product. Although we had important limitations, this case report supports the use of anti-TNF agents in highly mortal steroid-refractory acute GI GVHD and that replacement of infliximab with its biosimilars is feasible.
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis
Journal: Crystal Structures of PF-06438179/GP1111, an Infliximab Biosimilar. (Pubmed Central) - Oct 7, 2020
Use of an MBDA score based on serum biomarker levels provides a sensitive assessment of biosimilarity that is independent of DA measures, which require physical examination of the patient or subjective patient global assessment. The structures provide new insights into the physicochemical properties of the proposed biosimilar and the reference product, further strengthening the 'totality of evidence' in the evaluation of similarity.
- |||||||||| Ixifi (infliximab-qbtx) / Pfizer, Novartis, Hyrimoz (adalimumab-adaz) / Novartis
Trial primary completion date, Real-world evidence, Real-world: GIANT: Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease (clinicaltrials.gov) - Jun 22, 2020
P=N/A, N=1600, Recruiting,
The structures provide new insights into the physicochemical properties of the proposed biosimilar and the reference product, further strengthening the 'totality of evidence' in the evaluation of similarity. Trial primary completion date: May 2025 --> May 2020
- |||||||||| Review, Journal: Drugs for psoriatic arthritis. (Pubmed Central) - Feb 15, 2020
Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02222493). No abstract available
- |||||||||| 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.
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung, Avsola (infliximab-axxq) / Amgen
FDA event: FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq),for use in Crohns, UC, RA, AS, PsA and psoriasis, based on a 566 pt trial in RA. This is the 4th infliximab biosimilar in the US, joining Inflectra, Renflexis, and Ixifi. https://t.co/nFhyMM1OnK (Twitter) - Dec 11, 2019
- |||||||||| 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.
- |||||||||| Infimab (infliximab biosimilar) / Sun Pharma, Reliance Life Sciences, BCD-055 (infliximab biosimilar) / Biocad
Journal: The Experience With Biosimilars Of Infliximab In Rheumatic Diseases. (Pubmed Central) - Aug 1, 2019
In addition, the European experience has proved the economic advantages of the incorporation of infliximab biosimilars in clinical practice. Despite the widespread use of infliximab biosimilars there is still a lack of data regarding interchangeability between reference products and biosimilars.
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis
Review, Journal: The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product. (Pubmed Central) - Jun 23, 2019
Differences identified in N-glycosylation and charge heterogeneity were found not to impact the results in in vitro biological assays reflective of the pharmacology underlying the mechanisms of action (tumor necrosis factor binding, reverse signaling, antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity) of IFX across disease indications. Similarity was assessed in a comparative clinical pharmacokinetic study and in a clinical efficacy and safety study in patients with rheumatoid arthritis, where therapeutic equivalence between PF-SZ-IFX and ref-IFX provided confirmatory evidence of biosimilarity, and, when coupled with the analytical similarity already established, supported extrapolation to all eligible disease indications of ref-IFX.
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis
Clinical, Journal: A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. (Pubmed Central) - May 15, 2019
P3
Similarity was assessed in a comparative clinical pharmacokinetic study and in a clinical efficacy and safety study in patients with rheumatoid arthritis, where therapeutic equivalence between PF-SZ-IFX and ref-IFX provided confirmatory evidence of biosimilarity, and, when coupled with the analytical similarity already established, supported extrapolation to all eligible disease indications of ref-IFX. PF-06438179/GP1111 and infliximab-EU demonstrated similar efficacy, safety, immunogenicity, and PK with or without dose escalation in patients with moderate to severe active RA on background methotrexate.
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis
Journal: PF-06438179/GP1111: An Infliximab Biosimilar. (Pubmed Central) - May 7, 2019
The tolerability, immunogenicity and safety profiles of GP1111 were similar to those of reference infliximab, and switching from reference infliximab to GP1111 had no impact on safety, efficacy or immunogenicity. The role of reference infliximab in the management of autoimmune inflammatory conditions is well established and GP1111 provides an effective biosimilar alternative for patients requiring infliximab therapy.
- |||||||||| Ixifi (infliximab biosimilar) / Pfizer, Novartis
Clinical, P3 data, Journal: Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54. (Pubmed Central) - Apr 19, 2019
P3
The similar efficacy, safety and immunogenicity of PF-SZ-IFX compared with ref-IFX were maintained for up to 54 weeks and were not affected by blinded treatment switch from ref-IFX to PF-SZ-IFX at week 30. NCT02222493.
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