Abstract Number: 1443 • 2019 ACR/ARP Annual Meeting
Real World Switching Patterns of Etanercept Original and Biosilmilar in Germany
Background/Purpose: We have previously evaluated switching dynamics between etanercept biologic original (EtnBO) and etanercept biosimilars (EtnBS) over approximately 18 months following the first EtnBS launch…Abstract Number: 2520 • 2018 ACR/ARHP Annual Meeting
Efficacy of the Reference Biologic Agents in Two Different Types of Randomized Clinical Trials: 1/ the Ones Comparing Their Efficacy Vs. Placebo and 2/ the Ones Comparing Their Efficacy Vs. Biosimilar in Rheumatoid Arthritis: A Systematic Review of Literature and Meta-Analysis
Background/Purpose: Recent randomized clinical trials (RCTs) have shown similar efficacy of biosimilar agents compared to reference agents. Is the efficacy of reference biologic agents different…Abstract Number: 2539 • 2018 ACR/ARHP Annual Meeting
SB4 Shows Comparable Short-Term Effectiveness to Its Etanercept Originator As First-Line Biologic Treatment for Patients with Rheumatoid Arthritis in Routine Clinical Care
Background/Purpose: In the United Kingdom (UK) since 2016, etanercept biosimilars (SB4) are since 2016 a first-line treatment option for the management of severe rheumatoid arthritis…Abstract Number: 2442 • 2017 ACR/ARHP Annual Meeting
Biosimilar Candidate BI 695501 and Adalimumab Reference Product Have Similar Efficacy and Safety in Patients with Moderately-to-Severely Active Rheumatoid Arthritis (RA): 1-Year Results from a Phase III Study
Background/Purpose: Clinical equivalence has been shown for BI 695501 and the adalimumab reference product (RP) through similar ACR20 response at Weeks (wks) 12 and 24…Abstract Number: 2444 • 2017 ACR/ARHP Annual Meeting
Effectiveness and Safety of CT-P13 in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Plaque Psoriasis: Observational Study in Republic of Korea
Background/Purpose: CT-P13 is approved as a biosimilar of innovator infliximab for marketing in 81 countries. After approval, observational study has been conducted in Republic of…Abstract Number: 2495 • 2017 ACR/ARHP Annual Meeting
Biosimilarity between Humira® and the Biosimilar Candidate SB5 in Product Quality
Background/Purpose: A biosimilar is a biopharmaceutical product that is highly similar to an already licensed one in terms of quality, safety, and efficacy. We (Samsung…Abstract Number: 605 • 2016 ACR/ARHP Annual Meeting
Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects
Background/Purpose: 324 healthy volunteers were randomized 1:1:1 to receive a single 40 mg dose of M923, US-sourced reference adalimumab, or EU-sourced reference adalimumab by subcutaneous…Abstract Number: 8L • 2015 ACR/ARHP Annual Meeting
A Phase III, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week Results)
Background/Purpose: SB5 is a biologic agent developed as a biosimilar of the adalimumab reference product (ADL). Equivalence in pharmacokinetics (PK) between SB5 and ADL in…Abstract Number: 2055 • 2015 ACR/ARHP Annual Meeting
A Phase III, Randomized, Double-Blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (52-week Results)
Background/Purpose: SB4 is a biologic agent developed as a biosimilar of the etanercept reference product (ETN). This study was a randomized, double-blind, multicenter study and…Abstract Number: 2056 • 2015 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Phase III Study Comparing SB2, an Infliximab Biosimilar, to the Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 54-Week Results
Background/Purpose: SB2 is developed as a biosimilar of the infliximab reference product (INF). 30-week efficacy and safety results from a randomized phase III study were…
ACR Meeting Abstracts