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- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Safety and Usability of Infliximab Administration by Auto-injector (AI) and Pre-filled Syringe (PFS) in Patients with Active Rheumatoid Arthritis (RA): Patient-reported Experience from a Multicenter, Randomized Controlled Pivotal Trial () - Oct 8, 2020 - Abstract #ACRARHP2020ACR_ARHP_821;
Infliximab delivered by both AI and PFS was generally well-tolerated and the results demonstrated that there were no differences in usability between AI and PFS. The availability of both AI and PFS will allow patients to select a device based on their own preferences and experiences and will lead to increased adherence during long-term therapy
- || Remsima SC (infliximab biosimilar SC) / Celltrion
What about subcutaneous infliximab? (Twitter) - Oct 3, 2020
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Pivotal clinical trial of infliximab SC (Celltrion Healthcare) (Industry Exhibition) - Sep 26, 2020 - Abstract #UEGW2020UEGW_6525;
The availability of both AI and PFS will allow patients to select a device based on their own preferences and experiences and will lead to increased adherence during long-term therapy Sponsor: Celltrion Healthcare
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Pivotal Clinical Trial of Infliximab SC (Industry On-Demand) - Sep 16, 2020 - Abstract #UEGW2020UEGW_6415;
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Clinical Advances of Infliximab in IBD treatment: Infliximab SC (Celltrion Healthcare) (Industry On-Demand) - Sep 16, 2020 - Abstract #UEGW2020UEGW_6413;
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Pivotal Clinical Trial of Infliximab SC (Industry On-Demand) - Sep 16, 2020 - Abstract #UEGW2020UEGW_6409;
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Clinical Advances of Infliximab in IBD treatment: Infliximab SC (Celltrion Healthcare) (Industry On-Demand) - Sep 16, 2020 - Abstract #UEGW2020UEGW_6407;
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Pivotal Clinical Trial of Infliximab SC (Industry On-Demand) - Sep 16, 2020 - Abstract #UEGW2020UEGW_6403;
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Clinical Advances of Infliximab in IBD treatment: Infliximab SC (Celltrion Healthcare) (Industry On-Demand) - Sep 16, 2020 - Abstract #UEGW2020UEGW_6401;
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] EXPOSURE-RESPONSE RELATIONSHIP OF SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) IN PATIENTS WITH ACTIVE CROHN'S DISEASE AND ULCERATIVE COLITIS: ANALYSIS FROM A MULTICENTER, RANDOMIZED CONTROLLED PIVOTAL TRIAL (Hall 1) - Sep 12, 2020 - Abstract #UEGW2020UEGW_6261;
Positive association was demonstrated between the CT-P13 SC exposure and the efficacy/ FC outcomes in patients with active CD and UC. These data support the PK-PD basis for using CT-P13 SC as a novel, convenient and efficacious therapy formulation for CD and UC patients.
- |||||| Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Enrollment open, Trial initiation date: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) (clinicaltrials.gov) - Sep 2, 2020
P3, N=615, Recruiting, Sponsor: Celltrion
These data support the PK-PD basis for using CT-P13 SC as a novel, convenient and efficacious therapy formulation for CD and UC patients. Not yet recruiting --> Recruiting | Initiation date: Mar 2020 --> Sep 2020
- ||| Remsima SC (infliximab biosimilar SC) / Celltrion
European Commission expands approved indications for subcutaneous infliximab biosimilar https://t.co/dETt1QECbD (Twitter) - Jul 28, 2020
- ||| Remsima SC (infliximab biosimilar SC) / Celltrion
European Commission expands approved indications for subcutaneous infliximab biosimilar https://t.co/LbYyAbfK4E @HealioGastro (Twitter) - Jul 28, 2020
- Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] EVALUATION OF CLINICAL RELATIONSHIP BETWEEN FECAL CALPROTECTIN AND ENDOSCOPIC FINDINGS IN ULCERATIVE COLITIS PATIENTS TREATED WITH INFLIXIMAB (CT-P13) SUBCUTANEOUS AND INTRAVENOUS THERAPY: RESULTS FROM A MULTICENTER, RANDOMIZED, CONTROLLED PIVOTAL TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_4616;
This analysis of a controlled CT-P13 SC/IV clinical trial showed that FC levels are clearly associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients. These findings support FC as a noninvasive biomarker alternative to endoscopy for monitoring the mucosal response to infliximab (CT-P13) treatment in patients with UC.
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] EXPOSURE-RESPONSE RELATIONSHIP OF SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) IN PATIENTS WITH ACTIVE CROHN'S DISEASE AND ULCERATIVE COLITIS: ANALYSIS FROM A MULTICENTER, RANDOMIZED CONTROLLED PIVOTAL TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_4505;
Positive association was demonstrated between the CT-P13 SC exposure and the efficacy/ FC outcomes in patients with active CD and UC. These data support the PK-PD basis for using CT-P13 SC as a novel, convenient and efficacious therapy formulation for CD and UC patients.
- Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] EVALUATION OF CLINICAL RELATIONSHIP BETWEEN FECAL CALPROTECTIN AND ENDOSCOPIC FINDINGS IN ULCERATIVE COLITIS PATIENTS TREATED WITH INFLIXIMAB (CT-P13) SUBCUTANEOUS AND INTRAVENOUS THERAPY: RESULTS FROM A MULTICENTER, RANDOMIZED, CONTROLLED PIVOTAL TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_2640;
This analysis of a controlled CT-P13 SC/IV clinical trial showed that FC levels are clearly associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients. These findings support FC as a noninvasive biomarker alternative to endoscopy for monitoring the mucosal response to infliximab (CT-P13) treatment in patients with UC.
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] EXPOSURE-RESPONSE RELATIONSHIP OF SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) IN PATIENTS WITH ACTIVE CROHN'S DISEASE AND ULCERATIVE COLITIS: ANALYSIS FROM A MULTICENTER, RANDOMIZED CONTROLLED PIVOTAL TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_2529;
Positive association was demonstrated between the CT-P13 SC exposure and the efficacy/ FC outcomes in patients with active CD and UC. These data support the PK-PD basis for using CT-P13 SC as a novel, convenient and efficacious therapy formulation for CD and UC patients.
- Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] EVALUATION OF CLINICAL RELATIONSHIP BETWEEN FECAL CALPROTECTIN AND ENDOSCOPIC FINDINGS IN ULCERATIVE COLITIS PATIENTS TREATED WITH INFLIXIMAB (CT-P13) SUBCUTANEOUS AND INTRAVENOUS THERAPY: RESULTS FROM A MULTICENTER, RANDOMIZED, CONTROLLED PIVOTAL TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_656;
This analysis of a controlled CT-P13 SC/IV clinical trial showed that FC levels are clearly associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients. These findings support FC as a noninvasive biomarker alternative to endoscopy for monitoring the mucosal response to infliximab (CT-P13) treatment in patients with UC.
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] EXPOSURE-RESPONSE RELATIONSHIP OF SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) IN PATIENTS WITH ACTIVE CROHN'S DISEASE AND ULCERATIVE COLITIS: ANALYSIS FROM A MULTICENTER, RANDOMIZED CONTROLLED PIVOTAL TRIAL (Poster Exhibition) - Jul 19, 2020 - Abstract #UEGW2020UEGW_545;
Positive association was demonstrated between the CT-P13 SC exposure and the efficacy/ FC outcomes in patients with active CD and UC. These data support the PK-PD basis for using CT-P13 SC as a novel, convenient and efficacious therapy formulation for CD and UC patients.
- || Remsima SC (infliximab biosimilar SC) / Celltrion
approvalsWatch: EMA expands the indication of subcutaneous #infliximab to include #PsoriaticArthritis & #AnkylosingSpondylitis @EMA_News https://t.co/FDEL8R38j0 (Twitter) - Jul 3, 2020
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] How Subcutaneous Infliximab will be Updated on Guidelines for Rheumatoid Arthritis (Amor) - Jun 13, 2020 - Abstract #EULAR2020EULAR_4614;
- Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Pivotal clinical data of subcutaneous infliximab CT-P13 (Amor) - Jun 13, 2020 - Abstract #EULAR2020EULAR_4611;
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] Celltrion Healthcare: Beyond current treatment options: Infliximab SC (Amor) - Jun 13, 2020 - Abstract #EULAR2020EULAR_4608;
- ||| Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Trial completion: A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis (clinicaltrials.gov) - Jun 9, 2020
P1, N=181, Completed, Sponsor: Celltrion
These data support the PK-PD basis for using CT-P13 SC as a novel, convenient and efficacious therapy formulation for CD and UC patients. Active, not recruiting --> Completed
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] CLINICAL EVALUATION OF THE IMMUNOGENICITY TO CT-P13 FOR SUBCUTANEOUS USE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: 1-YEAR CLINICAL RESULTS FROM A MULTICENTER, RANDOMIZED CONTROLLED PIVOTAL TRIAL (Poster View) - May 22, 2020 - Abstract #EULAR2020EULAR_2919;
The analysis of both ADA positivity and titer is clinically meaningful in the prediction of PK profile and clinical response. CT-P13 SC administration did not result in a greater incidence of ADA compared to the CT-P13 IV and there were no clinical differences depending on the formulation.
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] BUDGET IMPACT ANALYSIS OF INTRODUCING SUBCUTANEOUS INFLIXIMAB CT-P13 SC FROM THE UK PAYER PERSPECTIVE () - May 22, 2020 - Abstract #EULAR2020EULAR_2790;
Self-injection will significantly reduce the burden on healthcare delivery allowing resource to be spent elsewhere. Sensitivity analysis concluded that treatment with increased IV dose will result in higher savings from switching patients to subcutaneous infliximab.
- Remsima SC (infliximab biosimilar SC) / Celltrion
[VIRTUAL] IMPACTS OF BODY MASS INDEX ON CLINICAL RESPONSE OF NOVEL SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: 1-YEAR RESULTS FROM A PART 2 OF PHASE I/III RANDOMIZED CONTROLLED TRIAL (Poster View) - May 22, 2020 - Abstract #EULAR2020EULAR_1948;
These post-hoc results showed that there was no impact of BMI on the clinical responses of CT-P13 SC 120 mg biweekly in RA patients. Therefore, CT-P13 SC 120 mg could be a reasonable therapeutic option regardless of BMI.
- ||||| Remsima SC (infliximab biosimilar SC) / Celltrion
Biosimilar launch: Celltrion Launches Remsima SC (biosimilar, infliximab) for the Treatment of Autoimmune Diseases in the Netherlands https://t.co/SE3qoYk05S (Twitter) - May 8, 2020
- ||| Remsima SC (infliximab biosimilar SC) / Celltrion, Humira (adalimumab) / Eisai, AbbVie
Clinical: We are reviewing all patients that were waiting to start biologics and delaying treatments in stable and no high-risk patients, and trying to start adalimumab instead of infliximab (sc por avoid hospital visits) in some patients. (Twitter) - Mar 18, 2020
- Remsima SC (infliximab biosimilar SC) / Celltrion
EVALUATION OF CLINICAL RELATIONSHIP BETWEEN FECAL CALPROTECTIN AND ENDOSCOPIC RESULT IN ULCERATIVE COLITIS PATIENTS TREATED WITH INFILXIMAB SUBCUTANEOUS AND INTRAVENOUS THERAPY: RESULTS FROM A MULTICENTER, RANDOMIZED, CONTROLLED PIVOTAL TRIAL () - Jan 28, 2020 - Abstract #DDW2020DDW_3496;
Therefore, CT-P13 SC 120 mg could be a reasonable therapeutic option regardless of BMI. This analysis using CT-P13 SC and IV clinical trial dataset confirmed that FC is significantly correlated with endoscopic disease activity in UC patients, supporting FC as a monitoring biomarker alternative to endoscopy in determining the achievement of MH, during infliximab treatment.
- Remsima SC (infliximab biosimilar SC) / Celltrion
A NOVEL SUBCUTANEOUS INFLIXIMAB (CT-P13) IN PATIENTS WITH ACTIVE CROHN’S DISEASE AND ULCERATIVE COLITIS: WEEK54 AND SWITCHING RESULTS FROM A MULTICENTER, RANDOMISED CONTROLLED PIVOTAL TRIAL () - Jan 28, 2020 - Abstract #DDW2020DDW_3321;
The PK as manifested by trough concentrations of the drug, increased after switching to SC from 6 months of IV dosing. These observations support the first infliximab SC formulation is a viable therapeutic agent whether used early after induction or whether patients switch from IV to SC during maintenance.
- Remsima SC (infliximab biosimilar SC) / Celltrion
Impact of administration route on pharmacokinetics and immunogenicity: Lessons from CT-P13 SC/IV development program (Lehar 1-3) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_836;
- Remsima SC (infliximab biosimilar SC) / Celltrion
Pivotal clinical data of subcutaneous infliximab CT-P13 SC (Lehar 1-3) - Jan 7, 2020 - Abstract #ECCOIBD2020ECCO_IBD_835;
- |||||||||| Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
New P3 trial: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) (clinicaltrials.gov) - Dec 18, 2019
P3, N=615, Not yet recruiting, Sponsor: Celltrion
- Remsima SC (infliximab biosimilar SC) / Celltrion
Satellite Symposium 1c - Celltrion Long-term and switching data of subcutaneous infliximab (Lehar 1-3) - Dec 3, 2019 - Abstract #ECCOIBD2020ECCO_IBD_504;
- Remsima SC (infliximab biosimilar SC) / Celltrion
A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s disease and ulcerative colitis (Plenary Hall) - Dec 3, 2019 - Abstract #ECCOIBD2020ECCO_IBD_62;
The PK as manifested by trough concentrations of the drug, increased after switching from IV to SC. These observations support the first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options.
- |||| Remsima SC (infliximab biosimilar SC) / Celltrion
The EMA has approved a subcutaneous version of Celltrion infliximab biosimilar, CT-P13 - now called Remsima SC; based on the phase I/III study showing equivalence between SC and IV forms of CT-P13 SC in active rheumatoid arthritis (RA). https://t.co/cJFEk464Wr (Twitter) - Nov 26, 2019
- ||| Remsima SC (infliximab biosimilar SC) / Celltrion
Launch Europe: .@CelltrionDream gears up for subcutaneous infliximab launch in Europe https://t.co/WIc2b0XRYE (Twitter) - Nov 26, 2019
- |||| Remsima SC (infliximab biosimilar SC) / Celltrion
Clinical: EMA has approved the subcutaneous version of CT-P13 an infliximab biosimilar based on this trial by Rene Westhovens. Equal efficacy of IV and SC CT-P13 with great maintenance on SC form. Interestingly high trough levels with SC CT-P13. #ACR19 @RheumNow Abst 807 (Twitter) - Nov 10, 2019
- || Remsima SC (infliximab biosimilar SC) / Celltrion
Infliximab SC is finally coming (Twitter) - Oct 22, 2019
- || Remsima SC (infliximab biosimilar SC) / Celltrion, Entyvio (vedolizumab) / Takeda
SC Infliximab & Vedolizumab will be a game changer - the 2020s will be exciting one for the developments in treatment... (Twitter) - Oct 17, 2019
- Remsima SC (infliximab biosimilar SC) / Celltrion
Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_1486;
The results after switching from CT-P13 IV 3 mg/kg to CT-P13 SC 120 mg at Week 30 were comparable to that of maintaining CT-P13 SC 120 mg up to Week 54. These results show that the novel SC formulation of CT-P13 via pre-filled syringe could provide a favorable benefit to patients with an alternative convenient way of administration
- Remsima SC (infliximab biosimilar SC) / Celltrion
Clinical Evidence of CT-P13 SC Formulation (A2) - Oct 4, 2019 - Abstract #UEGW2019UEGW_4298;
- Remsima SC (infliximab biosimilar SC) / Celltrion
CELLTRION - Pivotal data of subcutaneous infliximab (CELLTRION HEALTHCARE CO., LTD.) (A2) - Oct 4, 2019 - Abstract #UEGW2019UEGW_4296;
- Remsima SC (infliximab biosimilar SC) / Celltrion
NONINFERIORITY OF NOVEL SUBCUTANEOUS INFLIXIMAB (CT-P13) TO INTRAVENOUS INFLIXIMAB (CT-P13) IN PATIENTS WITH ACTIVE CROHN’S DISEASE AND ULCERATIVE COLITIS: WEEK 30 RESULTS FROM A MULTICENTRE, RANDOMISED CONTROLLED PIVOTAL TRIAL (F3) - Oct 4, 2019 - Abstract #UEGW2019UEGW_4218;
CT-P13 SC resulted in adequate trough level, achieving comparable clinical efficacy between the 2 formulations. It is anticipated that this novel formulation would facilitate and broaden access to efficacious and convenient therapy for the patients.
- || Remsima SC (infliximab biosimilar SC) / Celltrion
First subcutaneous infliximab recommended for approval by @EMA_News committee https://t.co/eywmfWK2JM (Twitter) - Oct 1, 2019
- ||| Remsima SC (infliximab biosimilar SC) / Celltrion
Clinical: Positive safety and efficacy results for subcutaneous infliximab biosimilar, CT-P13 (Remsima), was presented at EULAR 2019. In 48 RA pts, efficacy (DAS28,, ACR20) of CT-P13 SC was comparable to CT-P13-IV up to Week 54. https://t.co/84ismy7ci2 (Twitter) - Aug 27, 2019
- | Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Trial completion: A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA (clinicaltrials.gov) - Jul 24, 2019
P3, N=412, Completed, Sponsor: Celltrion
It is anticipated that this novel formulation would facilitate and broaden access to efficacious and convenient therapy for the patients. Active, not recruiting --> Completed
- | Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Enrollment open: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD) (clinicaltrials.gov) - Jul 18, 2019
P3, N=600, Recruiting, Sponsor: Celltrion
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
New P3 trial: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD) (clinicaltrials.gov) - May 9, 2019
P3, N=600, Not yet recruiting, Sponsor: Celltrion