- |||||||||| Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
Journal: Synthesis and evaluation of vanillin Schiff bases as potential antimicrobial agents against ESBL-producing bacteria: towards novel interventions in antimicrobial stewardship. (Pubmed Central) - Nov 19, 2024
The Schiff bases demonstrated notable antibacterial activities, with SB-1, SB-2, SB-4, and SB-5 exhibiting zones of inhibition up to 16.0, 16.5, 16.6, and 15.5 mm against ESBL E. coli, respectively...In cytotoxicity assays, the compounds exhibited IC values against red blood cells (RBCs) greater than 200 ?g/mL and ranging from 45.7 to 50.5 ?g/mL for the brine shrimp assay. While demonstrating potent antibacterial properties, the toxicity towards human RBCs suggests that further toxicity evaluations and structural modifications are essential for developing safer therapeutic agents based on vanillin Schiff bases.
- |||||||||| Optimizing Treatment Pathways for nAMD: Balancing Durability and Costs in the UK () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_312;
The study showed that ranibizumab biosimilars and aflibercept 2mg remain effective, innovative, and potentially cost-saving treatment options for retinal conditions such as nAMD. While faricimab and aflibercept 8mg show potential benefits in durability, their higher acquisition costs require careful evaluation against budget constraints.
- |||||||||| Avastin (bevacizumab) / Roche
Biomarker, Trial completion date, Trial primary completion date, Surgery: Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer (clinicaltrials.gov) - Oct 18, 2024
P3, N=3610, Active, not recruiting,
Active, not recruiting --> Completed Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / AbbVie
Adalimumab Biosimilar-to-biosimilar Switch in Patients with Inflammatory Rheumatic Diseases (In Person) - Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_1684;
A potential limitation was our assumption that every individual was under the same maintenance regimen (50 mg sc weekly). Starting in January 2021, a biosimilar-to-biosimilar adalimumab switch from SB5 (Imraldi
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp
Journal: Efficacy and Safety of Switching from Adalimumab Originator to SB5, Adalimumab Biosimilar for Noninfectious Uveitis. (Pubmed Central) - Sep 24, 2024
To evaluate the efficacy and safety of switching from adalimumab originator (Humira, AbbVie) to SB5, adalimumab biosimilar (Adalloce, Samsung Bioepis) in patients with noninfectious uveitis (NIU)...No other adverse events occurred after switching to SB5. Switching from adalimumab originator to SB5 for NIU does not result in clinically significant differences in treatment efficacy and safety.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Observational data, Retrospective data, Journal, Real-world evidence, Real-world: Real-world experience with biosimilar infliximab-adba and infliximab-dyyb among infliximab-na (Pubmed Central) - Sep 20, 2024
IFX utilization and laboratory patterns were clinically similar among the IFX biosimilars and RP groups, suggesting that providers did not modify their practice with biosimilars. Statistically significant differences in IFX utilization patterns are explained by formulary dynamics when the VANF product switched from IFX-dyyb to IFX-abda.
- |||||||||| Aybintio (bevacizumab biosimilar) / Samsung, Mundipharma
Journal: Unequal Spatial Consequences of Abortion Restrictions in Texas, 2021-2023. (Pubmed Central) - Sep 4, 2024
We used network analysis to determine the change in distance to the nearest surgical abortion provider for 5253 Texas neighborhoods after the passing of Texas Senate Bill 8 (SB8; 2021) and the US Supreme Court's Dobbs v Jackson Women's Health Organization (2022) decision...Published online ahead of print May 23, 2024:e1-e10. https://doi.org/10.2105/AJPH.2024.307652).
- |||||||||| Avastin (bevacizumab) / Roche, Avzivi (bevacizumab-tnjn) - Bio / Thera Solutions, Cipla, BeiGene, Biomm, Mega Lifesciences, Sandoz, Lynparza (olaparib) / Merck (MSD), AstraZeneca
New P3 trial: NRG-GY036: Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer (clinicaltrials.gov) - Aug 30, 2024
P3, N=880, Not yet recruiting,
- |||||||||| Vegzelma (bevacizumab-adcd) / Celltrion, Avastin (bevacizumab) / Roche, Avzivi (bevacizumab-tnjn) - Bio / Thera Solutions, Cipla, BeiGene, Biomm, Mega Lifesciences, Sandoz
Trial completion date, Combination therapy, Metastases: Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (clinicaltrials.gov) - Aug 7, 2024
P3, N=692, Active, not recruiting,
Trial completion date: Jul 2024 --> Jul 2025 Trial completion date: Jun 2024 --> Jun 2025
- |||||||||| Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
PK/PD data, Journal: Population Pharmacokinetic Analysis and Simulation of Alternative Dosing Regimens for Biosimilars to Adalimumab and Etanercept in Patients with Rheumatoid Arthritis. (Pubmed Central) - Jun 27, 2024
A simulation of dosing the etanercept biosimilar at a lower rate of every 10 days reached steady-state concentrations earlier than the usual dosing rate of every 7 days. Simulations of altered dosing intervals could form the basis for future personalised dosing studies, potentially saving costs whilst increasing efficacy.
- |||||||||| TAK-671 / Takeda, Samsung
Journal, Heterogeneity: Genetic Heterogeneity in Cowpea Genotypes (Vigna unguiculata L. Walp) Using DArTseq (GBS)-Derived Single Nucleotide Polymorphisms. (Pubmed Central) - Jun 27, 2024
The mean values for polymorphic information content, observed heterozygosity, expected heterozygosity, major allele frequency, and the inbreeding coefficient were 0.345, 0.386, 0.345, 0.729, and 0.113, respectively. Moreover, they validated the diversity of the evaluated cowpea genotypes, which could be used for potential breeding programmes and management of cowpea germplasm.
- |||||||||| Vegzelma (bevacizumab-adcd) / Celltrion, Avastin (bevacizumab) / Roche, Avzivi (bevacizumab-tnjn) - Bio / Thera Solutions, Cipla, BeiGene, Biomm, Mega Lifesciences, Sandoz
Trial completion date, Metastases: Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer (clinicaltrials.gov) - Jun 25, 2024
P3, N=394, Active, not recruiting,
Initiation date: Jun 2024 --> Nov 2024 Trial completion date: Jul 2024 --> May 2025
- |||||||||| Aybintio (bevacizumab biosimilar) / Samsung, Mundipharma
Journal: Infant Deaths After Texas' 2021 Ban on Abortion in Early Pregnancy. (Pubmed Central) - Jun 24, 2024
To examine whether Texas Senate Bill 8 (SB8), which banned abortions after embryonic cardiac activity and did not allow exemptions for congenital anomalies, is associated with infant mortality in the state of Texas...Although replication and further analyses are needed to understand the mechanisms behind these findings, the results suggest that restrictive abortion policies may have important unintended consequences in terms of trauma to families and medical cost as a result of increases in infant mortality. These findings are particularly relevant given the recent Dobbs v Jackson Women's Health Organization US Supreme Court decision and subsequent rollbacks of reproductive rights in many US states.
- |||||||||| Eylea (aflibercept intravitreal) / Bayer, Regeneron, Afilivu (aflibercept biosimilar) / AffaMed Therap, Biogen, Samsung
Journal: Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea (Pubmed Central) - Jun 15, 2024
These findings are particularly relevant given the recent Dobbs v Jackson Women's Health Organization US Supreme Court decision and subsequent rollbacks of reproductive rights in many US states. Based on a comprehensive analytical similarity assessment of structural, physicochemical, and biological properties, SB15 was demonstrated to be highly similar to US/EU-aflibercept RP, supporting safe and effective use of SB15.
- |||||||||| Byooviz (ranibizumab-nuna) / Samsung, AffaMed Therap, Biogen, Lucentis (ranibizumab) / Roche, Novartis
Clinical, Retrospective data, Journal: Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis. (Pubmed Central) - Jun 6, 2024
Post hoc analyses of the SB11-rRBZ equivalence study showed that baseline age, BCVA, CST, and total lesion area were prognostic factors for visual or anatomical outcomes of nAMD, while subgroup analyses demonstrated comparable results for SB11 and rRBZ. Collectively, the results appear comparable to similar RCTs of anti-vascular endothelial growth factor reference products for nAMD and strengthen confidence in the biosimilarity of SB11.
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon, Herceptin (trastuzumab) / Roche
P4 data, Journal: Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study. (Pubmed Central) - Jun 4, 2024
Collectively, the results appear comparable to similar RCTs of anti-vascular endothelial growth factor reference products for nAMD and strengthen confidence in the biosimilarity of SB11. Safety and efficacy of SB3 demonstrated in this real-world study were comparable with previous studies of reference trastuzumab.
- |||||||||| Epysqli (eculizumab biosimilar) / AffaMed Therap, Samsung, Soliris (eculizumab) / AstraZeneca
TRANSFUSION AVOIDANCE WITH EPYSQLI (Poster Area (Hall 7)) - May 15, 2024 - Abstract #EHA2024EHA_3699;
Transfusion avoidance by SB12 versus ECU treatments showed comparable results, although the small samplesize represents a limit to data interpretation. Overall, transfusion avoidance results support the previouslydemonstrated clinical efficacy of EPYSQLI (SB12), a biosimilar to reference eculizumab.
- |||||||||| Pyzchiva (ustekinumab biosimilar) / Samsung, Sandoz
"Totality -of-the-Evidence" of Proposed Ustekinumab Biosimilar SB17 (Studio 8-9 (6F)) - May 10, 2024 - Abstract #IMKASID2024IMKASID_281;
Results : In the analytical assessment, SB17 showed similarity to EU- and US-UST-RP in overall critical and non-critical quality attributes. 3 In a phase I study, SB17 and EU- and US-UST-RP had similar PK and comparable safety, tolerability, and immunogenicity.4 In a phase III study of patients with moderate-to-severe PsO, SB17 had equivalent efficacy, comparable safety and immunogenicity to UST-RP up to Week 28 (Table 1).5 Conclusion : With similar target binding and PK and confirmed similarity in efficacy and safety for PsO patients, SB17 is proposed to be highly similar to UST-RP in physicochemical, non-clinical, and clinical studies and data supports its extrapolation to UST-RP indications.
- |||||||||| Enrollment closed, Metastases: A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer (clinicaltrials.gov) - May 9, 2024
P2, N=88, Active, not recruiting,
3 In a phase I study, SB17 and EU- and US-UST-RP had similar PK and comparable safety, tolerability, and immunogenicity.4 In a phase III study of patients with moderate-to-severe PsO, SB17 had equivalent efficacy, comparable safety and immunogenicity to UST-RP up to Week 28 (Table 1).5 Conclusion : With similar target binding and PK and confirmed similarity in efficacy and safety for PsO patients, SB17 is proposed to be highly similar to UST-RP in physicochemical, non-clinical, and clinical studies and data supports its extrapolation to UST-RP indications. Recruiting --> Active, not recruiting
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon, Kanjinti (trastuzumab-anns) / Amgen, Daiichi Sankyo, AbbVie, Herceptin (trastuzumab) / Roche
Trastuzumab biosimilars interchangeability: Preliminary real-world data in neoadjuvant breast cancer setting. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4543;
Brazilian Ministry of Health, as the only provider, has a policy based on lowest cost for trastuzumab compound, causing constant changes along pts treatments. Furthermore, it is expected that Brazil has the potential to evaluate the IC in thousands of pts prospectively next years.
- |||||||||| Avastin (bevacizumab) / Roche
Biomarker, Trial completion date, Trial primary completion date, Surgery: Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer (clinicaltrials.gov) - Apr 11, 2024
P3, N=3610, Active, not recruiting,
Furthermore, it is expected that Brazil has the potential to evaluate the IC in thousands of pts prospectively next years. Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Mar 2024 --> Sep 2024
- |||||||||| Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / AbbVie
Adalimumab-bwwd, a biosimilar of adalimumab, has the potential for substantial cost savings when prescribed () - Apr 9, 2024 - Abstract #AMCP2024AMCP_152;
In a scenario based on publicly available pricing, substantial cost savings were generated from switching patients to adalimumab-bwwd. As confirmed by real-world experience of other biosimilar adoption in the United States, the magnitude of these savings is dif- ficult to predict because of invisible rebate structures but adoption of biosimilars would inevitably realize substan- tial savings to plans.
- |||||||||| Trial completion date, Metastases: Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer (clinicaltrials.gov) - Apr 4, 2024
P2, N=349, Active, not recruiting,
- |||||||||| SB16 (denosumab biosimilar) / Samsung
A RANDOMIZED, DOUBLE-BLIND, PHASE III STUDY TO COMPARE SB16 (PROPOSED DENOSUMAB BIOSIMILAR) TO REFERENCE DENOSUMAB IN PATIENTS WITH POSTMENOPAUSAL OSTEOPOROSIS: 18-MONTH RESULTS (Poster Tour 3) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1143;
As confirmed by real-world experience of other biosimilar adoption in the United States, the magnitude of these savings is dif- ficult to predict because of invisible rebate structures but adoption of biosimilars would inevitably realize substan- tial savings to plans. The efficacy, PK, PD, safety, and immunogenicity among the treatment groups (SB16+SB16, DEN+DEN, and DEN+SB16) were comparable up to Month 18.
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