- |||||||||| 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.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Journal: How similar is biosimilar? A comparison of Infliximab therapeutics in regard to charge variant profile and antigen binding affinity. (Pubmed Central) - Jul 19, 2019 We would therefore argue, that analytical comparison is not always a good predictor for clinical interchangeability. Any future regulatory framework for the approval of biosimilars should reflect that the parameters chosen for analytical comparability have to be chosen carefully.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Primer trabajo OP0277 en #Eular2019 que muestra la posible #intercambiabilidad, de #infliximab innovador a 2 #biosimilares diferentes consecutivos, CT-P13 y Sb2. Remicade, Inflectra y Flixavi. Resultados muy similares al parear perfil de paciente. #AnnRheumDis (Twitter) - Jul 4, 2019
- |||||||||| 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.
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical: As in how long it takes for the temporary symptoms of receiving the drug to wear off (in my case, very mild muscle aches on Remicade, but haven't had these at all with either Remsima or Flixabi). (Twitter) - Jun 2, 2019
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Clinical: Two ifx biosimilars approved in Canada. Inflectra (Pfizer) and Renflexis (Merck). Will be up to the individual MD’s to decide. Will be interesting to see which company picks up more market share. (Twitter) - May 29, 2019
- |||||||||| Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Journal: Full Interchangeability in Regard to Immunogenicity Between the Infliximab Reference Biologic and Biosimilars CT-P13 and SB2 in Inflammatory Bowel Disease. (Pubmed Central) - May 11, 2019 Findings suggest that immunodominant epitopes in the reference and CT-P13 drugs are equally present in SB2. Data support full interchangeability between biosimilars in regard to immunogenicity.
- |||||||||| 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, Remaloce (infliximab biosimilar) / Yuhan, Biogen, Ewopharma, Merck (MSD), Samsung
Review, Journal: Switching from infliximab to biosimilar in inflammatory bowel disease: overview of the literature and perspective. (Pubmed Central) - Apr 27, 2019 However, efficacy and safety data on Flixabi (SB2) in IBD patients is lacking. Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in IBD patients.
- |||||||||| 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, The number of biosimilars and time of entry of is critical to create competition which will result in maximum cost savings. 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
- |||||||||| Stelara (ustekinumab) / J&J
Enrollment change, Trial completion date, Trial primary completion date, Real-world evidence, Real-world effectiveness, Real-world: RUN-CD: Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn (clinicaltrials.gov) - Jul 13, 2018 P=N/A, N=900, Recruiting, Trial completion date: Oct 2018 --> Jan 2019 | Trial primary completion date: Aug 2018 --> Nov 2018 N=600 --> 900 | Trial completion date: May 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- |||||||||| 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, Not yet recruiting --> Recruiting 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
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