GP2015: An Etanercept Biosimilar
نویسندگان
چکیده
منابع مشابه
GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes
AIMS To assess pharmacokinetics (PK) and safety of GP2015, a proposed etanercept biosimilar, in two studies: comparison with etanercept originator (ETN, bioequivalence study) and comparison of GP2015 administered via an autoinjector (AI) or prefilled syringes (PFS, delivery study). METHODS Both studies were randomized, two-sequence, two-period, crossover studies conducted in healthy male subj...
متن کاملPhysicochemical Characterization of Altebrel™, a Proposed Etanercept Biosimilar
Background: Etanercept is prescribed for the rapid and effective treatment of chronic immune-mediated inflammatory disorders. Due to the expiration of etanercept patents and worldwide demand for comparable and more affordable substitutes, several biosimilars of etanercept have been approved in different countries and new ones are in the process of approval.Objectives: In the present study...
متن کاملComparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: another consideration.
In their 2015 publication, Emery et al reported findings of a phase III, randomised, double-blind study comparing the investigational etanercept biosimilar SB4 (Samsung Bioepis, Incheon, Korea) with the innovator etanercept in patients who have moderate-to-severe rheumatoid arthritis (RA) despite methotrexate treatment. Although the authors reported equivalent clinical efficacy between the SB4 ...
متن کاملResponse to: 'Comparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: another consideration' by Marshall et al.
We thank Marshall et al for the interest in and comments on our SB4 phase III study publication and subsequent correspondence regarding immunogenicity. Antidrug antibody (ADA) incidence in clinical trials varies widely and is dependent on both the ADA assay method and sampling schedule. In the SB4 phase III study, the Meso Scale Discovery (MSD) electrochemiluminescence (ECL) bridging assay (Mar...
متن کاملPerceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali®) Versus Etanercept (Enbrel®) - Findings from a Nurse Survey in Europe
INTRODUCTION Enbrel® (etanercept: manufactured by Immunex Corporation, Newbury Park, Thousand Oaks, CA 91320, USA) was the first biological disease-modifying anti-rheumatic drug approved for the treatment of rheumatoid arthritis (RA) in Europe. More recently, an etanercept biosimilar (Benepali®: manufactured by Biogen Inc, Cambridge, MA 02124, USA) was approved in the European Union. The percep...
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ژورنال
عنوان ژورنال: BioDrugs
سال: 2017
ISSN: 1173-8804,1179-190X
DOI: 10.1007/s40259-017-0246-1