- |||||||||| 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.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Review, Journal: Biosimilars in dermatology: The wind of change. (Pubmed Central) - Aug 7, 2019
The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Clinical, Review, Journal, HEOR, Real-World Evidence: Real-World Evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review. (Pubmed Central) - Aug 7, 2019
Nearly 2500 ETN-naïve patients have been initiated on SB4 and outcomes are similar to those patients receiving reference ETN. Overall this systematic review of real-world evidence provides additional reassurance that SB4 is as effective and safe as reference ETN in both switched and naïve patients.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Journal: Implementing and delivering a successful biosimilar switch programme - the Berkshire West experience. (Pubmed Central) - Aug 2, 2019
Drug acquisition costs were decreased by £95,000 with an overall reduction in prescribing costs of £186,000 for the local health economy. A managed switching programme from originator etanercept to biosimilar Benepali, using a novel fixed price model, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes and good patient experience.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Clinical, Journal: Open-Label Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: 6-Month Results From a Controlled Cohort Study. (Pubmed Central) - Jul 24, 2019
A managed switching programme from originator etanercept to biosimilar Benepali, using a novel fixed price model, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes and good patient experience. Non-mandatory transitioning from ENB to SB4 using a specifically-designed communication strategy showed a slightly lower persistence rate and smaller decreases in disease activity compared with a historical cohort, but these differences were considered as not being clinically relevant.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Clinical, Journal: Comparing Gly/dAla-Replacement vs. the in-Situ Neprilysin-Inhibition Approach on the Tumor-targeting Efficacy of the In-SB3/In-SB4 Radiotracer Pair. (Pubmed Central) - Jun 30, 2019
Replacement of Gly by dAla improved in vivo stability, however, at the cost of GRPR-affinity and cell uptake, eventually translating into inferior tumor uptake of In-SB4 vs. unmodified In-SB3. On the other hand, in-situ NEP-inhibition turned out to be a more efficient and direct strategy to optimize the in vivo profile of In-SB3, and potentially other peptide radiotracers.
- |||||||||| Erelzi (etanercept biosimilar) / Novartis, Enbrel (etanercept) / Takeda, Pfizer, Amgen
Journal: Etanercept for the treatment of rheumatoid arthritis. (Pubmed Central) - Jun 26, 2019
With the increasing number of etanercept biosimilars, there will likely be a resurgence of their prescription. This article reviews the pharmacology, efficacy and safety of the etanercept reference product, and its biosimilars, in the context of RA treatment.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Trial completion: BENEFIT: Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel (clinicaltrials.gov) - Jun 19, 2019
P=N/A, N=585, Completed,
This article reviews the pharmacology, efficacy and safety of the etanercept reference product, and its biosimilars, in the context of RA treatment. Recruiting --> Completed
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Journal: Etanercept biosimilar SB-4. (Pubmed Central) - Jun 9, 2019
In some areas, and more specifically when it comes to immunogenicity, SB-4 showed lower incidents. Therefore, it is fully expected to have same efficacy and safety in all indications.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Clinical, Journal: Clinical experience with the etanercept biosimilar SB4 in psoriatic patients. (Pubmed Central) - Jun 5, 2019
In cohort 2 at week 24 PASI 75 was observed in 75% of patients. Conclusion In our experience switching from originator to SB4 in psoriatic patients seems not to influence efficacy, especially cutaneous manifestations, over a median observational period of 24 weeks.
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen
Journal: High-throughput screens for agonists of bone morphogenetic protein (BMP) signaling identify potent benzoxazole compounds. (Pubmed Central) - May 7, 2019
Activation of BMP signaling by sb4 increased the phosphorylation of key second messengers (SMADs-1/5/9) and also increased expression of direct target genes (inhibitors of DNA binding, ID1 and ID3) in canonical BMP signaling. Our results underscore the feasibility of utilizing HTS to identify compounds that mimic key downstream events of BMP signaling in renal cells and yielded a lead BMP agonist.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Journal: Switching to biosimilars in the treatment of rheumatic diseases. (Pubmed Central) - Apr 9, 2019
Expert Commentary: Clear guidelines for switching and data from post-marketing surveillance and registries will be required to confirm existing results on the safety and efficacy of switching from bio-originators to biosimilars. To lessen the nocebo effect against biosimilars, effective educational programs should be provided for all stakeholders, including patients and physicians.
- |||||||||| Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
Trial completion: Benepali (clinicaltrials.gov) - Oct 23, 2018
P=N/A, N=500, Completed,
To lessen the nocebo effect against biosimilars, effective educational programs should be provided for all stakeholders, including patients and physicians. Recruiting --> Completed
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Trial completion date, Trial primary completion date: BENEFIT: Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel (clinicaltrials.gov) - Sep 17, 2018
P=N/A, N=600, Recruiting,
Recruiting --> Completed Trial completion date: Oct 2018 --> Jan 2019 | Trial primary completion date: Aug 2018 --> Nov 2018
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Phase classification: BENEFIT: Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel (clinicaltrials.gov) - Apr 3, 2018
P, N=600, Recruiting,
More RA patients used bDMARDs in recent years, and use of newer agents, including certolizumab, golumumab, and tocilizuamab, is rising, which highlights a need for further comparative safety and effectiveness research of these agents to better guide evidence-based decision making. Phase classification: P=N/A --> P
- |||||||||| Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
Trial primary completion date: Benepali (clinicaltrials.gov) - Dec 21, 2017
P=N/A, N=500, Recruiting,
Phase classification: P=N/A --> P Trial primary completion date: Dec 2017 --> Aug 2018
- |||||||||| Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma, Bionovis
New trial: Benepali (clinicaltrials.gov) - Oct 31, 2017
P=N/A, N=500, Recruiting,
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Sep 28, 2017
P2, N=50, Completed,
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects (clinicaltrials.gov) - Sep 5, 2017
P1, N=50, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - Jul 21, 2017
P2, N=50, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects (clinicaltrials.gov) - Jun 20, 2017
P1, N=50, Active, not recruiting,
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (clinicaltrials.gov) - Dec 6, 2015
P3, N=596, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Nov 2014 --> Apr 2014
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (clinicaltrials.gov) - Apr 15, 2015
P3, N=498, Active, not recruiting,
Active, not recruiting --> Completed | Trial primary completion date: Nov 2014 --> Apr 2014 Trial primary completion date: Jun 2014 --> Nov 2014
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (clinicaltrials.gov) - Dec 9, 2013
P3, N=498, Active, not recruiting,
Trial primary completion date: Jun 2014 --> Nov 2014 Recruiting --> Active, not recruiting
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects (clinicaltrials.gov) - Dec 9, 2013
P1, N=138, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (clinicaltrials.gov) - Jul 8, 2013
P3, N=498, Active, not recruiting,
- |||||||||| Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan Corp, Mundipharma, Biogen
Clinical: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects (clinicaltrials.gov) - May 29, 2013
P1, N=138, Completed,
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