- |||||||||| [VIRTUAL] CHARACTERIZATION OF PATIENTS WITH ANKYLOSING SPONDYLITIS WHO INITIATED SECUKINUMAB: ELECTRONIC HEALTH RECORDS DATA FROM THE COLUMBUS REPOSITORY (Poster View) - May 22, 2020 - Abstract #EULAR2020EULAR_2048;
Physician and patient characteristics, and treatment patterns were reported for patients who were prescribed secukinumab and TNFis (adalimumab, etanercept, certolizumab pegol, infliximab, infliximab-abda, and golimumab)...Secukinumab initiators were more likely to have prior opioid use vs TNFi initiators but were less likely to have prior methotrexate use ( Figure 2 A ); 67% of secukinumab initiators and 49% of TNFi initiators were biologic experienced, of whom 73% and 76%, respectively, used 1 prior biologic, 25% and 20% used 2 prior biologics, and 2% and 4% used ≥ 3 prior biologics ( Figure 2 B )... Secukinumab initiators with AS were younger and more opioid and biologic experienced, were more likely to have a PsA diagnosis, and were more likely to discontinue their previous biologic because the biologic was no longer required compared to patients who initiated TNFis.
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Enrollment change, Trial completion date, Trial primary completion date: PERFUSE: One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study (clinicaltrials.gov) - Mar 30, 2020 P=N/A, N=3000, Recruiting, No abstract available N=1500 --> 3000 | Trial completion date: Jul 2021 --> Jun 2022 | Trial primary completion date: Jul 2021 --> Jun 2022
- |||||||||| Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
New P2 trial, Checkpoint inhibition: Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (clinicaltrials.gov) - Mar 12, 2020 P2, N=42, Not yet recruiting,
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Entyvio (vedolizumab) / Takeda, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
[VIRTUAL] LONGITUDINAL EVALUATION OF PRODUCT UTILIZATION AND CHARACTERISTICS AMONG PATIENTS TREATED WITH BIOLOGIC ANTI-INFLAMMATORY AGENTS- A STUDY BY THE BIOLOGICS AND BIOSIMILARS COLLECTIVE INTELLIGENCE CONSORTIUM. () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_91; A total of 651 incident users of the biosimilar infliximab-dyyb (4.2% of all infliximab use), and 39 new users (0.2%) of infliximab-abda were observed...The proportion of rituximab users declined from 64.7% of all non-TNF use in 2012 to 37.9% in 2017, while use of newer products including vedolizumab and secukinumab have gradually increased to 9.6% and 12.9%, respectively, by 2017...With multiple biosimilars and new innovator products becoming available we expect the market shares will continue to shift. This is important information to inform future research in AIs in the BBCIC DRN.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
[VIRTUAL] LOWER DRUG PRICES IN MEDICARE- IMPACT OF BIOSIMILAR INTRODUCTION () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_69; Conclusions Entry of biosimilar competition correlated with declining Medicare Part B payments for both innovator products and their biosimilars. As a result, the federal government and patients have benefited not only from lower-cost biosimilars, but also from declining prices of reference products.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
The Budget Impact of a Biosimilar Transition Policy for Rheumatoid Arthritis Patients in Alberta () - Feb 19, 2020 - Abstract #CRAAHPA2020CRA-AHPA_249; A transition policy to biosimilars could reduce healthcare system costs although the savings may not be as high as expected depending on the implementation policy and retention rates. Further analyses should include costs beyond the drug costs as well as patient outcomes.
- |||||||||| Review, Journal: Drugs for psoriatic arthritis. (Pubmed Central) - Feb 15, 2020
who found that there were no significant differences in discontinuation risk between etanercept originator and biosimilar SB4. 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.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical: Lack of penetration of infliximab #biosimilars: Is this news to anyone? https://t.co/exCoAnYQzi @pfizer @JanssenGlobal #remicade #inflectra #renflexis (Twitter) - Feb 5, 2020
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
SAFETY AND CLINICAL EFFICACY OF DOUBLE SWITCH FROM ORIGINATOR INFLIXIMAB TO BIOSIMILARS CT-P13 AND SB2 IN PATIENTS WITH INFLAMMATORY BOWEL DISEASES (SCESICS): A MULTICENTRE STUDY. () - Jan 28, 2020 - Abstract #DDW2020DDW_3128; Conclusion. The study support both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
SWITCHING INFLIXIMAB BIOSIMILAR: NO ADVERSE IMPACT ON IBD CONTROL OR DRUG LEVELS WITH FIRST OR SECOND SWITCH () - Jan 28, 2020 - Abstract #DDW2020DDW_2212; In a cohort of IBD patients switching to a new IFX biosimilar either for the first or second time, an increase in IFX level was observed with no impact on clinical and biochemical disease activity indices. Switching IFX biosimilars in IBD appears safe in the short term with respect to maintaining drug pharmacokinetic profile and disease control whether switching for the first or second time.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal, Real-World Evidence: The Role of Biosimilars in Uveitis: Long-Term Real-World Outcomes of the Switch From Original to Biosimilar TNF-Alpha Inhibitors. (Pubmed Central) - Jan 12, 2020 No statistically significant changes were observed in the BCVA (p = 0.27), CMT (p = 0.50), frequency of UME (p = 0.57) and daily corticosteroid intake (p = 0.42) between the time of the switch and the last follow-up visit. The switch to biosimilars represents a feasible treatment choice associated with the maintenance of clinical efficacy in patients with non-infectious uveitis previously treated with the corresponding originator anti-TNF-α biologic agents.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Switching infliximab biosimilar: No adverse impact on inflammatory bowel disease control or drug levels with the first or second switch (Hall C - Poster exhibition) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1395; Conclusion In a cohort of IBD patients switching to a new IFX biosimilar either for the first or second time, an increase in IFX level was observed with no impact on clinical and biochemical disease activity indices. Switching IFX biosimilars in IBD appears safe in the short term with respect to maintaining drug pharmacokinetic profile and disease control whether switching for the first or second time.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
SPOSIB SB2: a Sicilian prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar SB2 (Hall C - Poster exhibition) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1335; Safety and efficacy of SB2 seem to be overall similar to those reported for IFX originator and IFX biosimilar CT-P13. A higher incidence of SAEs was observed among patients naive to IFX and previously exposed to other anti-TNFs.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Safety and clinical efficacy of double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicentre study (Hall C - Poster exhibition) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_1270; No differences in IFX discontinuation, AE and clinical remission rates were found between double-switched and single-switched patients. No clinical parameters were found to predict safety and efficacy outcomes.Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications.
- |||||||||| Preclinical, Enrollment change, Trial completion date, Trial termination, Trial primary completion date: RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis (clinicaltrials.gov) - Dec 24, 2019
P=N/A, N=250, Terminated, No clinical parameters were found to predict safety and efficacy outcomes.Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications. N=720 --> 250 | Trial completion date: Dec 2018 --> Dec 2019 | Recruiting --> Terminated | Trial primary completion date: May 2018 --> Dec 2019
- |||||||||| budesonide / Generic mfg., Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Drug-Induced Liver Injury (DILI) Associated With Anti-tumor Necrosis Factor Alpha (Anti-TNFα) Agent () - Dec 11, 2019 - Abstract #AIBD2019AIBD_65; Acute liver injury caused by anti-TNFα antagonist may be a class effect since several agents in this category have been implicated. In this case, the most common presentation occurred as an autoimmune phenotype with marked hepatocellular injury.
- |||||||||| Biosimilar Tote-Board in Rheumatology: 4 Infliximab biosimilars - Inflectra, Renflexis, Ifixi, Avsola 5 Adalimumab biosimilars - Amjevita, Cyltezo, Hyrimoz, Hadlima, Abrilada 2 Etanercept biosimilars - Erelzi, Enticovo 2 Rituximab biosimilars - Truxima, Ruxience (Twitter) - Dec 11, 2019
- |||||||||| 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
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Journal: Antiproliferative, neurotoxic, genotoxic and mutagenic effects of toxic cyanobacterial extracts. (Pubmed Central) - Nov 27, 2019 SB4, Oscillatoria earlei SB5, Phormidium sp...On the other hand, all concentrations of five toxic cyanobacterial extracts induced DNA damage between 3.0% and 1.3% of tail intensity and did not cause any direct mutagenic effect at the 1000 µg/plate cyanobacterial extracts. These results suggest that cyanobacteria-derived MCLR is a promising candidate for development of effective agents against colon cancer.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Humira (adalimumab) / Eisai, AbbVie, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Indeed. At Guy's & St Thomas' £££ savings are ploughed back into the #IBD service. I want to say 50% (?) but don't quote me on that... I know it contributes to IBD nurse funding. I've had no problems at all (Remicade - Remsima - Flixabi). Pt disquiet seems ++ with Humira biosims. (Twitter) - Nov 24, 2019
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Adverse events: I also hear more people complaining about side effects after switching to a biosimilar like remsima, inflectra or flixabi. (Twitter) - Nov 24, 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.
- |||||||||| 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
- |||||||||| Erelzi (etanercept biosimilar) / Novartis
Review, Journal: Review of Biosimilar Trials and Data on Etanercept in Rheumatoid Arthritis. (Pubmed Central) - Oct 24, 2019 Trial data demonstrates subtle differences in clinical outcomes and adverse events between the biosimilars and the reference product (RP). The development of etanercept biosimilars may reduce the financial burden of treating RA, but real-world data regarding efficacy and safety in comparison to the RP will be vital to assess for meaningful differences.
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