Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4
Sign Up to like & getrecommendations! Published in 2017 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2017-211591
Abstract: Objectives SB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period… read more here.
Keywords: efficacy safety; sb4 sb4; sb4; etn sb4 ... See more keywords
SAT0173 Switching from reference product etanercept to the biosimilar sb4 in a real-life setting: follow-up of 147 patients
Sign Up to like & getrecommendations! Published in 2017 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2017-eular.4391
Abstract: Background The etanercept biosimilar SB4 was introduced in Sweden in early 2016. SB4 has been shown in a randomized controlled trial to be equivalent to its etanercept reference product (ERP) in terms of efficacy and… read more here.
Keywords: sb4; treatment; biosimilar sb4; reference product ... See more keywords
Mandatory, cost-driven switching from originator etanercept to its biosimilar SB4: possible fallout on non-medical switching
Sign Up to like & getrecommendations! Published in 2018 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2018-214757
Abstract: We read with great interest the recently published results from DANBIO registry on switching from originator etanercept (ETA) to the biosimilar SB4.1 The study includes a really impressive number of patients who underwent mandatory switching… read more here.
Keywords: biosimilar sb4; medical switching; sb4; originator etanercept ... See more keywords
THU0222 Multiswitching – from reference product etanercept to biosimilar and back again – real-world data from a clinic-wide multiswitch experience
Sign Up to like & getrecommendations! Published in 2018 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2018-eular.2769
Abstract: Background The etanercept (ETN) biosimilar SB4 was introduced in Sweden in 2016 at a lower price than the reference product etanercept (RPE). Now the reverse is true, as the price of RPE dropped. Switching ETN-treated… read more here.
Keywords: back rpe; cohort; sb4; days 543 ... See more keywords
AB0473 Immunogenicity of biosimilars for rheumatic diseases: an updated review from regulatory documents and confirmatory clinical trials
Sign Up to like & getrecommendations! Published in 2018 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2018-eular.3076
Abstract: Background Several biosimilars have been approved for the treatment of rheumatic diseases by the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA). Objectives To summarise immunogenicity data from regulatory documents or… read more here.
Keywords: immunogenicity; pfizer; rheumatic diseases; documents confirmatory ... See more keywords
Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects
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DOI: 10.2147/dddt.s224103
Abstract: Purpose SB4 is an etanercept biosimilar, approved by the European Commission (EC) and the US Food and Drug Administration (FDA) following a demonstration of equivalent efficacy and safety and comparable quality data to the reference… read more here.
Keywords: safety tolerability; pre filled; pfs; sb4 ... See more keywords