Avsola (infliximab-axxq) News

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|||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Avsola (infliximab-axxq) / Amgen
Clinical, Retrospective data, Journal: Comparison of Reference and Biosimilar Medications for Pediatric Noninfectious Uveitis. (Pubmed Central) - Oct 31, 2024
Compared with the reference infliximab, pediatric patients had fewer number of flares per year on biosimilar infliximab, but they were also on the biosimilar for a shorter duration of time compared with the reference which may confound an accurate assessment. Biosimilar infliximab had a lower cost profile compared with reference infliximab.

||||||||||  Uvadex/Therakos Photopheresis (methoxsalen/ECP) / Mallinckrodt
New P2 trial, Checkpoint inhibition:  EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) -  Oct 17, 2024
P2, N=30, Not yet recruiting,  Sponsor: Therakos, LLC, a Mallinckrodt Company

|||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
A Survey Among IBD Patients Following Switching From Originator Infliximab to Its Biosimilars (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3058;
Biosimilar infliximab had a lower cost profile compared with reference infliximab. Since 2016, the FDA has approved three IFX biosimilar agents (SB2), Renflexis

|||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Avsola (infliximab-axxq) / Amgen
Reimbursement, US reimbursement, Journal, Medicare, Medicaid: Patterns of infliximab biosimilar uptake for Medicare, Medicaid, and private insurance from 2016-2022. (Pubmed Central) - Jul 30, 2024
Second, Medicare, which covers most patients receiving biologics nationally, had slow adoption rates even after the third biosimilar was introduced. Policy levers to speed adoption among Medicare beneficiaries are needed.

||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Trial completion date, Trial primary completion date, Adverse events:  PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) -  Mar 21, 2024
P2, N=36, Recruiting,  Sponsor: Massachusetts General Hospital
Policy levers to speed adoption among Medicare beneficiaries are needed. Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2023 --> Jun 2025

||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Trial completion date, Trial primary completion date, Checkpoint inhibition:  Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (clinicaltrials.gov) -  Mar 15, 2024
P2, N=42, Recruiting,  Sponsor: Massachusetts General Hospital
Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2023 --> Jun 2025 Trial completion date: Jun 2023 --> Jun 2030 | Trial primary completion date: Jun 2023 --> Jun 2030

|||||||||| Phase classification: CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - Feb 15, 2024
P4, N=900, Recruiting, Sponsor: Connecticut Children's Medical Center
Trial completion date: Jun 2023 --> Jun 2030 | Trial primary completion date: Jun 2023 --> Jun 2030 Phase classification: P --> P4

|||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Journal: Outcomes of the use of infliximab biosimilars in rheumatology and gastroenterology clinics. (Pubmed Central) - Jan 2, 2024
We conclude that the effort to convert clinically stable patients to a biosimilar product resulted in a significant increase in biosimilar use within the health system. This is thought to have resulted in significant financial advantages both to our institution as well as patients, without sacrificing overall clinical control.

|||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Comparing Uptake of Biosimilar Infliximab Among Patients with Medicare, Medicaid and Private Insurance in U.S. Rheumatology Practices 2016-2022 (Room 33A-C; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1787;
Medicare uptake lagged significantly. To reduce drug spending, efforts are needed to understand poor Medicare uptake of biosimilars such as manufacturer rebates for biologics, and lack of financial incentives to switch to biosimilars.

|||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Avsola (infliximab-axxq) / Amgen
Therapeutic Hemicolectomy for Intractable Hemorrhage in New-Onset Fistulizing Crohn (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_2716;
Figure: Figure 1: Multiple oozing ulcers visualized in the descending colon Figure 2: Active bleeding visualized throughout the ascending colon Figure 3: Large clot present in the sigmoid colon. Figure 4: Normal appearing ileum with an iatrogenic petechia.

||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Enrollment open, Trial initiation date:  REMODEL-CD: Precise Infliximab Exposure and Pharmacodynamic Control (clinicaltrials.gov) -  Jul 20, 2023
P2/3, N=180, Recruiting,  Sponsor: Children's Hospital Medical Center, Cincinnati
Figure 4: Normal appearing ileum with an iatrogenic petechia. Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023

|||||||||| Journal: Expanded table: Some drugs for inflammatory bowel disease. (Pubmed Central) - Jul 11, 2023
Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023 No abstract available

|||||||||| Enrollment open: CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - Jul 10, 2023
P=N/A, N=900, Recruiting, Sponsor: Connecticut Children's Medical Center
No abstract available Not yet recruiting --> Recruiting

|||||||||| Trial completion date, Trial initiation date, Trial primary completion date: CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - Apr 24, 2023
P=N/A, N=900, Not yet recruiting, Sponsor: Connecticut Children's Medical Center
Not yet recruiting --> Recruiting Trial completion date: Apr 2029 --> Jul 2029 | Initiation date: Apr 2023 --> Jul 2023 | Trial primary completion date: Apr 2028 --> Jul 2028

|||||||||| Avsola (infliximab-axxq) / Amgen
TREATMENT PATTERNS OF AN INFLIXIMAB BIOSIMILAR (ABP 710) AMONG PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD): A RETROSPECTIVE US CLAIMS DATABASE ANALYSIS (South Hall A, Poster Hall - McCormick Place) - Mar 23, 2023 - Abstract #DDW2023DDW_6340;
The switch back rate to an IFX originator was generally low. Reasons for switching and differences in switching patterns between IFX-na

|||||||||| New trial: CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - Mar 23, 2023
P=N/A, N=900, Not yet recruiting, Sponsor: Connecticut Children's Medical Center

|||||||||| BCD-055 (infliximab biosimilar) / Biocad
Retrospective data, Journal: Comparative efficacy and safety of infliximab and its biosimilars in patients with rheumatoid arthritis presenting an insufficient response to methotrexate : A (Pubmed Central) - Mar 6, 2023
Reasons for switching and differences in switching patterns between IFX-na No significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations.

|||||||||| Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Journal: Risankizumab (Skyrizi) - An IL-23 antagonist for Crohn's disease. (Pubmed Central) - Dec 22, 2022
No significant difference in ACR20 response rates and SAEs were detected between infliximab biosimilars and the originator in the investigated study populations. No abstract available

||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
New P2/3 trial:  REMODEL-CD: Precise Infliximab Exposure and Pharmacodynamic Control (clinicaltrials.gov) -  Dec 21, 2022
P2/3, N=180, Not yet recruiting,  Sponsor: Children's Hospital Medical Center, Cincinnati

|||||||||| Avsola (infliximab-axxq) / Amgen
Clinical: I am talking about infusion center. Our hospital doesn’t have avsola so was forced to send patient to outside center where it was on formulary (Twitter) - Oct 22, 2022

|||||||||| Avsola (infliximab-axxq) / Amgen
Has happened numerous times (especially since avsola not on formulary at PCH so have to send elsewhere). Nightmare getting labs and levels when outside center. Not a fan. (Twitter) - Oct 21, 2022

||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Enrollment open, Adverse events:  PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) -  Apr 8, 2022
P2, N=36, Recruiting,  Sponsor: Massachusetts General Hospital
No abstract available Not yet recruiting --> Recruiting

|||||||||| Avsola (infliximab-axxq) / Amgen
Review, Journal: A Review of the Totality of Evidence for the Development and Approval of ABP 710 (AVSOLA), an Infliximab Biosimilar. (Pubmed Central) - Mar 9, 2022
Safety and immunogenicity were also demonstrated to be similar for both ABP 710 and the RP. Overall, the TOE supported the conclusion that ABP 710 is highly similar to infliximab RP and supported scientific justification for extrapolation to all approved indications of infliximab RP, including IBD.

|||||||||| Journal: Expanded Table: Some biologic drugs and JAK inhibitors for rheumatoid arthritis. (Pubmed Central) - Feb 8, 2022
Overall, the TOE supported the conclusion that ABP 710 is highly similar to infliximab RP and supported scientific justification for extrapolation to all approved indications of infliximab RP, including IBD. No abstract available

|||||||||| Journal: Ozanimod (Zeposia) for ulcerative colitis. (Pubmed Central) - Oct 7, 2021
No abstract available No abstract available

|||||||||| 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.

|||||||||| 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:  PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) -  Sep 5, 2021
P2, N=36, Not yet recruiting,  Sponsor: Massachusetts General Hospital

|||||||||| Avsola (infliximab-axxq) / Amgen
FDA event: I believe Avsola was approved by FDA in December 2019 and went on the market in the U.S. July 2020. (Twitter) - Jul 8, 2021

|||||||||| Avsola (infliximab-axxq) / Amgen
Clinical: Cigna says patients can use Avsola, is this even available in the US???? (Twitter) - Jul 8, 2021

|||||||||| Avsola (infliximab-axxq) / Amgen
Clinical, PK/PD data, Journal: Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single-Blind, Single-Dose, Parallel-Group Study in Healthy Subjects. (Pubmed Central) - May 29, 2021
These results add to the totality of evidence providing further support that the proposed biosimilar ABP 710 is similar to infliximab RP. (Trial ID: ACTRN12614000903684.).

|||||||||| Clinical, FDA event: 4/ For 2021, newest med policy is mandated switches from @JanssenUS #Remicade 2 #Inflectra/#Avsola; @genentech #Rituxan 2 #Truxima AND #Ruxience, the later not @US_FDA approved for #RA so patients on #Ruxience NOT eligible for financial assistance thru manufacturer= unaffordable. (Twitter) - Mar 20, 2021

|||||||||| Avsola (infliximab-axxq) / Amgen
Journal: Analytical and Functional Similarity Assessment of ABP 710, a Biosimilar to Infliximab Reference Product. (Pubmed Central) - Mar 16, 2021
(Trial ID: ACTRN12614000903684.). Based on the comprehensive analytical similarity assessment, ABP 710 was found to be highly analytically similar to infliximab RP for all biological activities relevant for clinical efficacy and safety.

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung, Avsola (infliximab-axxq) / Amgen
Clinical: @UHC coverage for Infliximab. As of Feb 2021,prefers Inflectra or Avsola. What about existing patients on Remicade or Renflexis? @askUHC @IBDMD @ibddoctor @SchairerIBDMD @mchiorean4 @SCKimCHP @JeanneTungMD https://t.co/vrR9xcy9th (Twitter) - Feb 21, 2021

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung, Avsola (infliximab-axxq) / Amgen
Growing concerns about this *forced switch*. Only allowed to use Remicade or Renflexis is shown failure to respond to Inflectra or Avsola for 14 weeks ? @ACRheum @AmerGastroAssn @AmCollegeGastro @CrohnsColitisFn https://t.co/DWZMT6bqVM (Twitter) - Feb 21, 2021

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Avsola (infliximab-axxq) / Amgen
Clinical, Reimbursement, Adverse events: My insurance is forcing me to switch from Remicade after 11 years to either inflectra or avsola. I have heard only anecdotal stories abt inflectra & they were not ideal. Can you point me to any studies or give me any insight about the efficacy and side effects of these drugs. Thx (Twitter) - Feb 3, 2021

|||||||||| Avsola (infliximab-axxq) / Amgen
Clinical, Journal: Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis. (Pubmed Central) - Jan 13, 2021
P3
Although we were unable to statistically confirm non-superiority, post hoc analysis was supportive of non-superiority. DAS28-CRP, ACR20, ACR50, ACR70, and hybrid ACR evaluations over the entire study were consistently comparable as were safety and immunogenicity.

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Avsola (infliximab-axxq) / Amgen
Clinical: In April, and to be effective in July, @UHC announced it was #Remicade and #Inflectra. In December, and to be effective 2/1, is #Inflectra and #Avsola. It is NEVER about the patient. #stoprebates Cc: @ArthritisSTL @ACRheum @CSROAdvocacy @NORMGrp @Amgen @JanssenUS @pfizer (Twitter) - Dec 27, 2020

|||||||||| Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
[VIRTUAL] Use of infliximab and its biosimilars at a pediatric academic medical center () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2425;
Once data has been fully collected, all patient specific information will be omitted to maintain confidentiality. To assess the appropriateness of use, the dose based on indication and weight will be evaluated; cost of biosimilars on 340B pricing for outpatient use, as well as wholesale acquisition cost (WAC) for inpatient and outpatient use will be evaluated based on current usage of the originator product.

|||||||||| [VIRTUAL] Biosimilar cost versus reimbursement comparison in oncology practice () - Dec 26, 2020 - Abstract #ASHP2020ASHP_1190;
Herceptin, when compared with the biosimilar Kanjinti, gave better reimbursements for Medicare and private insurance. Biosimilars can be feasible depending on the patient’s insurance provider and the type of biosimilar being used.

|||||||||| Avsola (infliximab-axxq) / Amgen
Clinical, HEOR: Got my first request for a patient to use Avsola instead of Remicade (which she has been on for 10 years) yesterday. No healthcare system in SE WI even carries on formulary. Biosimilar availability is going to complicate “cost saving measures” (Twitter) - Dec 1, 2020

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
[VIRTUAL] A Devastating Case of Transverse Myelitis in an Inflectra-Treated Crohn’s Disease Patient () - Sep 15, 2020 - Abstract #ACG2020ACG_2325;
Introduction: Infliximab, sold under the brand names Remicade, Inflectra, Renflexis, and Avsola, is a tumor necrosis factor-α inhibitor (TNFα-I) that treats Crohn’s Disease (CD)...Inflectra was subsequently stopped, high dose prednisone was administered, and he received plasmapharesis...While biosimilar drugs are considered to be generic forms of originator biologics, they have subtle molecular differences that can lead to devastating side effects. An adverse drug reaction should be considered in any TNFα-I-treated patient with acute neurologic complaints.

||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Enrollment open, Trial initiation date, Checkpoint inhibition:  Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (clinicaltrials.gov) -  Aug 31, 2020
P2, N=42, Recruiting,  Sponsor: Massachusetts General Hospital
An adverse drug reaction should be considered in any TNFα-I-treated patient with acute neurologic complaints. Not yet recruiting --> Recruiting | Initiation date: Apr 2020 --> Aug 2020

||||||||||  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,  Sponsor: Massachusetts General Hospital

|||||||||| Review, Journal: Drugs for psoriatic arthritis. (Pubmed Central) - Feb 15, 2020
Not yet recruiting --> Recruiting | Initiation date: Apr 2020 --> Aug 2020 No abstract available

|||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Avsola (infliximab-axxq) / Amgen
.@FDAOncology approves @Amgen's Avsola for same indications as Remicade - https://t.co/PRtaKmnObG (Twitter) - Dec 19, 2019

|||||||||| 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

|||||||||| ABP 710 (infliximab biosimilar) / Amgen
Efficacy and Safety Results from a Phase 3 Study of Biosimilar Candidate ABP 710 in Subjects with Moderate to Severe RA (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_1458;
Safety was also found to be similar between treatment groups. In addition to previously reported primary efficacy endpoints, these secondary efficacy results support clinical similarity between ABP 710 and infliximab RP with respect to safety and efficacy.

|||||||||| ABP 710 (infliximab biosimilar) / Amgen
Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_1457;
Table 1 20190603 Abbreviations: CI = confidence interval; HAQ-DI = Health Assessment Questionnaire - Disability Index; RD = response difference. Note: The point estimate of RD was estimated by the Mantel-Haenszel estimate and the 90% CI was estimated using stratified Newcombe confidence limits adjusting for actual stratification factors.



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