Ewopharma News - LARVOL Sigma

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|||||||||| Eticovo (etanercept-ykro) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Observational data, Journal: Outcome of adult patients with JIA treated with the biosimilar Benepali: results of the biologic register JuMBO. (Pubmed Central) - Dec 16, 2022
Tolerability and effectiveness of the biosimilar Benepali were satisfactory and therapy survival was comparable to the originator. Further data on therapy with biologics and biosimilars such as Benepali must be collected by registries such as BiKeR and JuMBO in order to optimize therapy and patient outcomes and to reduce costs in the health system in the long term.

|||||||||| Eticovo (etanercept-ykro) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
P4 data, Journal, Real-world evidence: Safety and Effectiveness of Etanercept Biosimilar SB4 for Rheumatic Diseases in South Korea: Real-World Post-marketing Surveillance Data. (Pubmed Central) - Dec 10, 2022
Further data on therapy with biologics and biosimilars such as Benepali must be collected by registries such as BiKeR and JuMBO in order to optimize therapy and patient outcomes and to reduce costs in the health system in the long term. This first real-world evidence of SB4 from a phase IV PMS study in Korea shows comparable effectiveness to historical SB4 real-world evidence without any new significant safety signals.

|||||||||| Eticovo (etanercept-ykro) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Effectiveness of SB4 Transition from Originator Etanercept in Rheumatoid Arthritis and Axial Spondyloarthritis: A Subgroup Analysis from the BENEFIT Study. (Pubmed Central) - Dec 6, 2022
Both the cohorts are representative of typical patients with long-standing established diagnoses. Most of the patients transitioned to the same dose regimen of biosimilar as that received for the originator, and the regimen remained unchanged at 6 months, supporting the effectiveness of the transition.

|||||||||| Eticovo (etanercept-ykro) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: First report of Curtobacterium flaccumfaciens pv. flaccumfaciens causing bacterial tan spot of soybean in Russia. (Pubmed Central) - Dec 6, 2022
Ten isolates (SB1 to SB4 from Stavropol, F-125-1 to F-125-3 from Ryazan, and F-30-1 to F-30-3 from Amur) were selected, and further identified by morphological, physiological, and biochemical properties, MALDI TOF MS, 16S rRNA sequences, and specific primers CffFOR2 and CffREV4 (Tegli et al...To the best of our knowledge, this is the first report of C. flaccumfaciens pv. flaccumfaciens causing a bacterial tan spot of soybean in Russia.

||||||||||  Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Trial completion:  PERFUSE: One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study (clinicaltrials.gov) -  Oct 18, 2022
P=N/A, N=2274, Completed,  Sponsor: Biogen
flaccumfaciens causing a bacterial tan spot of soybean in Russia. Active, not recruiting --> Completed

|||||||||| Eticovo (etanercept-ykro) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Observational data, Journal: Post-switch Effectiveness of Etanercept Biosimilar Versus Continued Etanercept in Rheumatoid Arthritis Patients with Stable Disease: A Prospective Multinational Observational Study. (Pubmed Central) - Oct 5, 2022
Active, not recruiting --> Completed SB4 demonstrated comparable effectiveness to ETN over 12 months in patients with stable RA who voluntarily switched to the biosimilar in a real-world setting.

|||||||||| Humira (adalimumab) / Eisai, AbbVie
Long-term Follow-up of Starting and Switching from Bio-originator to Biosimilar: Real-world Data in Axial Spondyloarthritis Patients Treated with Adalimumab and Etanercept (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2026;
Response to treatment was also similar between groups. Drug survival in the three adalimumab groups (originator adalimumab – blue line, biosimilar adalimumab – red line, and switch from originator to biosimilar adalimumab – green line)Drug survival in the three etanercept groups (originator etanercept – blue line, biosimilar etanercept – red line, and switch from originator to biosimilar etanercept – green line)

|||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden. (Pubmed Central) - Sep 10, 2022
Drug survival in the three adalimumab groups (originator adalimumab – blue line, biosimilar adalimumab – red line, and switch from originator to biosimilar adalimumab – green line)Drug survival in the three etanercept groups (originator etanercept – blue line, biosimilar etanercept – red line, and switch from originator to biosimilar etanercept – green line) This large observational study supports the equivalence of biologic DMARD biosimilar products and originators when used in routine rheumatology care.

|||||||||| Recurrent Salmonella Associated With Relapse of Inflammatory Bowel Disease (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_3965;
Difficile infections remain in remission longer than to those infected with C. Difficile itself. With salmonella and IBD relapse, antibiotics are helpful in severe cases, but more research should be done to establish definite guidelines.

|||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Cost Analysis of Inpatient Originator Infliximab (Remicade) vs Biosimilar Infliximab (Renflexis) for Acute Severe Ulcerative Colitis: A Cost Minimization Study (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_3508;
No differences were found in baseline or discharge clinical parameters including baseline CRP (P=0.64), alb (P=0.1294), Hgb (P=0.5051), discharge CRP (P=0.1244), alb (P=0.8728), Hgb (P=0.4875), or CR-30 (23.53% vs. 29.41%, p=0.6975) (Table 1). Median rDSDC was 0.387 vs.

|||||||||| Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Infliximab Clearance and Exposure Are Comparable Between Originator Remicade and Biosimilars in Clinical Gastroenterology Practice (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_2051;
Overall, the PK were comparable between Originator and Biosimilars, although a small trend toward higher Clearance was observed in patients who received Biosimilars as compared to those who received Originator IFX (0.277±0.004 vs 0.262±0.001 L/day, respectively) (p< 0.001). Higher ATI’s were observed with Biosimilars vs Originator (19% [136/714] vs 15% [1320/8876], respectively) (p< 0.001) as well as lower exposure (7.6±0.3 vs 8.5±0.1 µg/mL, respectively) (p< 0.001).

|||||||||| Erelzi (etanercept-szzs) / Novartis
Journal: Effectiveness and safety of a biosimilar-to-biosimilar switch of the TNF inhibitor etanercept in patients with chronic inflammatory rheumatic diseases. (Pubmed Central) - Sep 3, 2022
The retention rate after switches from originator ETN to two ETN bsDMARD was close to 90%. Multiple switches resulted in a high adherence rate without clinically important efficacy or safety signals.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Biosimilar versus originator etanercept: a real-life clinical study. (Pubmed Central) - Aug 5, 2022
Multiple switches resulted in a high adherence rate without clinically important efficacy or safety signals. Overall, we can confirm the overlapping clinical efficacy between ETN and its biosimilar SB4 drug and that even in an uncontrolled environment such as real-life, the biosimilar drugs are an excellent opportunity to reduce health costs allowing to expand the audience of patients who can benefit from these innovative treatments.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Predicting Loss of Efficacy after Non-Medical Switching: Correlation between Circulating TNF-α Levels and SB4 in Etanercept to SB4 Switchers and Naïve Patients with Rheumatic Disease. (Pubmed Central) - Jul 29, 2022
Moreover, in naïve patients, DL and TNF-α levels were higher in NR than in NNR. Monitoring DL and TNF-α levels may represent a future precision medicine approach to predict loss of efficacy after NMS.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Observational data, Journal, Real-world evidence: Effectiveness and safety of original and biosimilar etanercept (Enbrel® vs Benepali®) in bDMARD-naïve patients in a real-world cohort of Portugal. (Pubmed Central) - Jul 17, 2022
Benepali® and Enbrel® demonstrated similar effectiveness and safety in RA, PsA and SpA in our cohort of patients. These data corroborate that the original and biosimilar drugs have similar quality characteristics and biological activity.

||||||||||  Cejemly (sugemalimab) / CStone Pharma
Trial primary completion date, Combination therapy, Metastases:  GEMSTONE-303: A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma (clinicaltrials.gov) -  Jun 30, 2022
P3, N=479, Active, not recruiting,  Sponsor: CStone Pharmaceuticals
These data corroborate that the original and biosimilar drugs have similar quality characteristics and biological activity. Trial primary completion date: Apr 2022 --> Sep 2022

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Review, Journal: TNFα inhibitor biosimilars associated with alopecia areata. Case-based review. (Pubmed Central) - May 26, 2022
In this report, we describe two patients, a 32-year-old woman with ankylosing spondylitis and a 48-year-old man with rheumatoid arthritis who were both treated with SB4 (Benepali), an etanercept biosimilar, and developed AA, 6 and 12 months respectively after the initiation of TNFα blocker biosimilar...Thus, physicians when dealing with patients treated with these agents, should be aware of possible immune skin reactions, among them AA. To this end, a close follow-up and monitoring is mandatory.

|||||||||| Humira (adalimumab) / Eisai, AbbVie
ANTI-TNFα: ORIGINATORS vs BIOSIMILARS, COMPARISON IN CLINICAL RESPONSE ASSESSMENT IN A MULTICENTER COHORT OF PATIENTS WITH INFLAMMATORY ARTHROPATHIES () - May 24, 2022 - Abstract #EULAR2022EULAR_3344;
Real-life data demonstrated the same safety between biosimilars and originators but a reduced biosimilar retention rate at 24 months, about 76%. Despite their loss efficacy, biosimilars could be considered valid and safe, and a good and less expensive alternative to the originators, allowing access to these innovative treatments to a wider patient population.

|||||||||| Trial completion date, Trial primary completion date: FREE: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (clinicaltrials.gov) - May 18, 2022
P4, N=148, Recruiting, Sponsor: University Medical Center Groningen
Despite their loss efficacy, biosimilars could be considered valid and safe, and a good and less expensive alternative to the originators, allowing access to these innovative treatments to a wider patient population. Trial completion date: Apr 2022 --> Jun 2023 | Trial primary completion date: Apr 2022 --> Jun 2023

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: A comparison between BMP4 and SB4 in inducing germ line gene expression pattern during embryonic stem cells differentiation. (Pubmed Central) - May 6, 2022
Moreover, co-presence of both BMP4 and SB4 could increase the expression level of Prdm14, Nnose3 and Stella (Dppa3), and thereby improve establishment of the germ cell fate during in-vitro differentiation of embryonic stem cells. In summary, our data suggest that SB4 could improve germ line gene expression pattern induced by BMP4 during embryonic stem cells in-vitro differentiation.

|||||||||| Enrollment closed: NeuMRA: Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients (clinicaltrials.gov) - May 3, 2022
P=N/A, N=212, Active, not recruiting, Sponsor: Vastra Gotaland Region
In summary, our data suggest that SB4 could improve germ line gene expression pattern induced by BMP4 during embryonic stem cells in-vitro differentiation. Recruiting --> Active, not recruiting

||||||||||  Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Enrollment open, Adverse events, Combination therapy, Metastases:  PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) -  Apr 8, 2022
P2, N=36, Recruiting,  Sponsor: Massachusetts General Hospital
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Preclinical, Review, Journal, HEOR, Real-world evidence: A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence. (Pubmed Central) - Apr 7, 2022
The infliximab biosimilar SB2 was approved in the EU (2016, Flixabi®) and the US (2017, Renflexis®) for the same indications as the reference product (Remicade®) based on a robust analytical and clinical data package...Switching from originator or biosimilar infliximab to SB2 including both single and multiple switches was not associated with an increased risk of loss of treatment response or any safety or immunogenicity concerns. Overall, the approved infliximab biosimilar SB2 is safe and effective in clinical practice across licensed indications.

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Observational data, Journal: Comparison of Performances of Infliximab Biosimilars CT-P13 Versus SB2 in the Treatment of Inflammatory Bowel Diseases: A Real-Life Multicenter, Observational Study in Italy. (Pubmed Central) - Apr 7, 2022
Higher MH rate was obtained in CD patients treated with CT-P13 (p=0.004). This first comparative study found that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients.

|||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Comparing the Effectiveness and Safety Associated With Infliximab vs Infliximab-abda Therapy for Patients With Hidradenitis Suppurativa. (Pubmed Central) - Mar 26, 2022
This cohort study found that both infliximab administration and infliximab-abda administration were associated with similar and significant improvement in disease as measured by the Hidradenitis Suppurativa Clinical Response. Infliximab-abda is likely a reasonable treatment option for hidradenitis suppurativa, and further research is warranted.

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
REAL WORLD OUTCOMES OF NON-MEDICAL SWITCHING OF INFLIXIMAB BIOSIMILAR IN BRITISH COLUMBIA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD) ([VIRTUAL]) - Mar 25, 2022 - Abstract #CDDW2022CDDW_149;
Conclusions In this small subset of the BC IBD population undergoing a non-medical biosimilar switch of infliximab, there was no difference in the discontinuation rate between the biosimilars or the originator infliximab molecule. These findings are consistent with the existing real-world evidence.

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
SIMILAR OUTCOMES IN PATIENTS SWITCHED TO INFLIXIMAB BIOSIMILARS COMPARED TO THOSE REMAINING ON REMICADE IN A BRITISH COLUMBIA INFLAMMATORY BOWEL DISEASE PRACTICE ([VIRTUAL]) - Mar 25, 2022 - Abstract #CDDW2022CDDW_147;
Other clinical outcomes were similar between Remicade and biosimilar patients in the full group of 113 patients. Conclusions IBD patients remaining on Remicade or switching to biosimilars demonstrated similar patient outcomes after a 6-month period.

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Safety of Rapid Infliximab Biosimilar Infusions in Patients With Inflammatory Bowel Disease. (Pubmed Central) - Mar 11, 2022
Rapid infusion of infliximab biosimilars (including infliximab-abda) and in patients who have switched among originator infliximab and biosimilars is well tolerated. Future studies should assess clinical impact and outcomes of rapid infusion with biosimilars.

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Change in Persistence between Biologic and Biosimilar of Infliximab in the US (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_590;
Other factors like treatment switches and administrative burden of reimbursement of medical benefit drugs should be evaluated. This can help manufacturers, payers, and providers to make changes in their awareness campaigns of drugs and try to increase the persistence.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: High fiber content snack bars made with maize biomass flour, rice flakes and oat flakes: Physicochemical properties and sensory acceptance. (Pubmed Central) - Mar 8, 2022
SB4 (containing 14.85:5:10.85% of MBF:RF:OF, respectively) and SB6 (containing 14:8:8% of MBF:RF:OF, respectively) were the closest to the desirable formulation according to the desirability diagram for the physicochemical properties of the SBs...The SB6 presented the highest sensory acceptance and purchase intent, highlighting its rich content of dietary fiber (16.45 ± 0.1 g 100 g) and protein (7.04 ± 0.02 g 100 g) besides its low-calorie characteristic (1421.22 kJ 100 g/339.68 kcal 100 g). The development of SBs using MBF is feasible in relation to their physicochemical and sensory properties, which can stimulate the sustainable production of new goods from this by-product.

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study. (Pubmed Central) - Mar 4, 2022
The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical, Journal: Training Distribution During a Paralympic Cycle for a Multiple Swimming Champion With Paraplegia: A Case Report. (Pubmed Central) - Mar 3, 2022
This strategy may be associated with potential cost implications. This case study exemplifies how a female Paralympic swimmer with paraplegia progressed her training in the seasons leading up to the Paralympic Games, reaching an annual training distance of 2000 km, which is similar to that of able-bodied swimmers.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: Texas law SB4 bans mail order pills and telehealth consultations for abortions, imposing fines and jail time. This violates a woman's right to access a medication that is effective at preventing pregnancy & has been deemed safe & appropriate by the FDA. https://t.co/J7BGPPJNmP (Twitter) - Feb 25, 2022

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study. (Pubmed Central) - Feb 16, 2022
Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients.

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical, Journal: The SPOSIB SB2 Sicilian Cohort: Safety and Effectiveness of Infliximab Biosimilar SB2 in Inflammatory Bowel Diseases, Including Multiple Switches. (Pubmed Central) - Feb 8, 2022
This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients. The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13.

|||||||||| Journal: Expanded Table: Some biologic drugs and JAK inhibitors for rheumatoid arthritis. (Pubmed Central) - Feb 8, 2022
The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13. No abstract available

|||||||||| Erelzi (etanercept biosimilar) / Novartis
Retention and Tolerability of Mandated Biosimilar Switching for Etanercept and Infliximab at One Year: A Large Single-Centre Experience in British Columbia ([VIRTUAL]) - Feb 3, 2022 - Abstract #CRAAHPA2022CRA_AHPA_143;
Overall, switching from Enbrel and Remicade to an approved biosimilar as mandated by BC Pharmacare for rheumatology indications was well tolerated in this review, with 78% of patients remaining on their biosimilar one year after the policy was implemented. There were no significant differences in the odds of retention based on medication or disease type between rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.

||||||||||  Cejemly (sugemalimab) / CStone Pharma
Enrollment closed, Combination therapy, Metastases:  GEMSTONE-303: A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma (clinicaltrials.gov) -  Feb 1, 2022
P3, N=479, Active, not recruiting,  Sponsor: CStone Pharmaceuticals
There were no significant differences in the odds of retention based on medication or disease type between rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. Recruiting --> Active, not recruiting

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Etanercept originator versus its biosimilar (SB4) for the treatment of rheumatoid arthritis. Are they truly similar? (Alsh 1) - Jan 30, 2022 - Abstract #BSR2022BSR_18;
Recruiting --> Active, not recruiting This analysis is the first to our knowledge to show similar outcomes amongst biologic-naïve patients with RA treated with either ETN-O or ETN-B using real-world data, which brings further evidence for similarity between the drugs.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Outcomes after switching from etanercept originator to its biosimilar (SB4) for the treatment of rheumatoid arthritis (Alsh 1) - Jan 30, 2022 - Abstract #BSR2022BSR_17;
Among the sub-cohorts of patients who discontinued ETN-B, differences were observed regarding the frequency and reasons for treatment withdrawal. These results will support UK rheumatologists and patients with treatment decisions, assist quality improvement projects to reduce drug withdrawals and refine biologic treatment delivery in the UK.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Modulation of Double Zwitterionic Block Copolymer Aggregates by Zwitterion-Specific Interactions. (Pubmed Central) - Jan 28, 2022
The PCB2-b-PSB4 aggregates were dissociated by the addition of nondetergent sulfobetaine (SB4) and carboxybetaine (CB2) molecules, while the aggregates showed different aggregation modulation processes for SB4 and CB2...The PCB2-b-PSB4 aggregate modulation efficiency of SBs associated with the intercharge hydrocarbon spacer length (CSL) rather than the symmetry with the SB in the PSB chain. These zwitterion-specific modulation behaviors were rationalized based on the nature of zwitterions including partial charge density, dipole moment, and hydrophobic interactions depending on the charged groups and CSL.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Genetic Diversity and Population Structure of Sorghum [Sorghum Bicolor (L.) Moench] Accessions as Revealed by Single Nucleotide Polymorphism Markers. (Pubmed Central) - Jan 26, 2022
Hence, crossbreeding genotypes from different clusters and evaluating their progenies for desirable traits is advantageous. The exceptionally high heterozygosity observed in accession SB4 and SB21 from the western geographic region is an intriguing finding of this study, which merits further investigation.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Ultrastructure of the Sensilla on the Antennae and Mouthparts of Bean Weevils, Megabruchidius dorsalis (Coleoptera: Bruchinae). (Pubmed Central) - Dec 24, 2021
There were seven types and eight subtypes of antennal sensilla, including Bőhm bristles (BB), two subtypes of sensilla trichoid (ST1, ST2), two subtypes of sensilla chaetica (SC1, SC2), four subtypes of sensilla basiconic (SB1, SB2, SB3, SB4), sensilla cavity (SCa), sensilla auricillica (SA), and sensilla gemmiformium (SG)...We discussed potential function related to structure via comparisons with previous investigations of bruchids and other insects. Our results provide a theoretical basis for further studies on sensory physiological function, using semiochemicals as effective biological controls of M. dorsalis.

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Journal: Collision-Induced Unfolding Reveals Stability Differences in Infliximab Therapeutics under Native and Heat Stress Conditions. (Pubmed Central) - Dec 16, 2021
Furthermore, we collected our comprehensive IM-MS and CIU data across two instrument platforms (Waters G2 and Agilent 6560), with both producing similar abilities to differentiate mAbs while also revealing minor differences between the results obtained on the two instruments. Finally, we demonstrate that CIU-based heatmaps and classification allow for rapid assessment of the most differentiating charge states for the analysis of infliximab, and using multiplexed classification, we conservatively estimate a 30-fold improvement in the time required to perform mAb stability and HOS measurements over standard DSC tools.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical, Observational data, Journal, HEOR: Effectiveness, safety and economic analysis of Benepali in clinical practice. (Pubmed Central) - Dec 16, 2021
Finally, we demonstrate that CIU-based heatmaps and classification allow for rapid assessment of the most differentiating charge states for the analysis of infliximab, and using multiplexed classification, we conservatively estimate a 30-fold improvement in the time required to perform mAb stability and HOS measurements over standard DSC tools. The biosimilar Benepali is as effective and safe as the original and much more cost-effective.

|||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical: Similarly, in a different study, double switching from IFX to biosimilar CT-P13 and then to another biosimilar SB2 did not affect effectiveness, immunogenicity, and safety of anti-TNF therapy (Aliment Pharmacol Ther. 2021 Apr;53(8):887-899). #AGAExpertX (Twitter) - Dec 8, 2021

|||||||||| Remaloce (infliximab biosimilar) / Yuhan Corp, Biogen, Ewopharma, Merck (MSD), Samsung
Journal: Comparison of Sb2-Infliximab with Originator-Infliximab in the Measurement of Serum Concentrations A Short Communication. (Pubmed Central) - Nov 21, 2021
The originator and SB-2 biosimilar-infliximab behaved similarly in several currently utilized assays in terms of their concentrations in biological fluids. Clinicians can be confident that therapeutic drug monitoring using platforms designed and developed for the originator-infliximab can be applied to SB-2-infliximab.

|||||||||| TNFcept (etanercept biosimilar) / LG Chem, Mochida
Retrospective data, Journal: Comparative efficacy and safety of etanercept biosimilars in comparison with etanercept in patients with rheumatoid arthritis who have insufficient response to methotrexate: A network meta-analysis. (Pubmed Central) - Nov 21, 2021
Clinicians can be confident that therapeutic drug monitoring using platforms designed and developed for the originator-infliximab can be applied to SB-2-infliximab. No significant difference was found between etanercept biosimilars and etanercept originators in patients with active RA despite treatment with MTX in terms of the ACR20 response rate and SAEs.

|||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Entyvio (vedolizumab) / Takeda, Humira (adalimumab) / Eisai, AbbVie
Clinical, Journal: Utilization patterns and characteristics of users of biologic anti-inflammatory agents in a large, US commercially insured population. (Pubmed Central) - Nov 16, 2021
As more biologics enter the market, greater variation in the use of biologics with similar indications and between biologic originators and biosimilars is anticipated. Because information on efficacy and safety at the time of drug approval is limited, post-marketing surveillance and research is needed to monitor medication safety and evaluate effectiveness between biologic drugs using real-world data.

|||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Journal: Observation of the fine structure of antennal sensilla of the stink bug, Eocanthecona furcellata (Hemiptera: Pentatomidae). (Pubmed Central) - Oct 30, 2021
SB4 was found only on females and SCo2 was found only on males...The morphology and putative functions of each sensilla were compared and discussed. These results provide a reference for further study of the behavioral biology, chemical ecology and electrophysiology of insects, and also provides a scientific basis for new ways of biological control.



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