TuNEX (etanercept biosimilar) / TTY Biopharm, Mycenax - LARVOL DELTA

Efficacy and safety of current therapies for difficult-to-treat rheumatoid arthritis: a systematic review and network meta-analysis. (PubMed, J Transl Med) - "Tocilizumab and rituximab have better efficacy and safety in the treatment of D2T RA, and the 8 mg/4w dose of tocilizumab may be the first choice for achieving disease remission."

Clinical • Journal • Retrospective data • Review • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL6

Complete mapping of disulfide linkages for etanercept products by multi-enzyme digestion coupled with LC-MS/MS using multi-fragmentations including CID and ETD. (PubMed, J Food Drug Anal) - "A total of 29 disulfides, Cys18-Cys31, Cys32-Cys45, Cys35-Cys53, Cys56-Cys71, Cys74-Cys88, Cys78-Cys-96, Cys98-Cys104, Cys112-Cys121, Cys115-Cys139, Cys-142-Cys157, Cys163-Cys178 in TNFR portion and Cys240-Cys240, Cys246-Cys246, Cys249-Cys249, Cys281-Cys341, Cys387-Cys445 in IgG1 Fc domain, were completely assigned with the demonstration of the same disulfide linkages between the Enbrel® and TuNEX® products. The data showed the higher order structure was preserved throughout the recombinant manufacturing processes and consistent between the two products."

Journal

Characterization and comparability of stress-induced oxidation and deamidation on vulnerable sites of etanercept products. (PubMed) - J Chromatogr B Analyt Technol Biomed Life Sci - "The bioactivity of both products remained unaltered by oxidative stress but was reduced by alkali stress. In conclusion, our data indicated that TuNEX(®) exhibits a similar chemical stress profile as that of Enbrel(®) in terms of oxidation and deamidation as well as bioactivity."

Journal • Biosimilar

A phase III study to evaluate the efficacy and safety of ENIA11 in combination with methotrexate versus methotrexate alone in patients with RA (clinicaltrials.gov) - P3, N=129; Sponsor: TSH Biopharm Corporation Limited; Not yet recruiting; New P3 trial

New P3 trial • Phase shift • Rheumatoid Arthritis

Unexpected outcomes: Development and evaluation of STEM programs that promote confidence and build friendships (ACS-Sp 2017) - "This presentation will explore Curiosity Academy’s key tools for curriculum design to cultivate self-development and friendships. Finally, directors will use previous evaluation experiences to provide suggestions for effective, accurate assessment."

Biosimilar

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=98; Active, not recruiting; Sponsor: TSH Biopharm Corporation Limited; Trial completion date: Dec 2017 ➔ Dec 2019

Trial completion date • Biosimilar • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis

A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - P3; N=10; Terminated; Sponsor: Mycenax Biotech Inc.; N=90 ➔ 10; Recruiting ➔ Terminated; Trial primary completion date: Dec 2018 ➔ Jan 2018; Sponsor's decision

Clinical • Enrollment change • Trial primary completion date • Trial termination