In the present study, secukinumab, a fully human IL-17A inhibitor, with
etanercept, a recombinant TNF receptor-immunoglobulin G fusion protein, was compared using pooled IPD from the FUTURE 2 (NCT01752634) (13), FUTURE 3 (NCT01989468) (14), and FUTURE 5 (NCT02404350) (15) trials for secukinumab and aggregate data from the NCT00317499 trial for
etanercept (16) in a target population of biologic-naive patients with PsA.
Before trial, Sandoz acknowledged that its biosimilar
etanercept infringes seven patent claims in U.S.
"Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for
etanercept to 2029.
The researchers identified 17,018 individuals with autoimmune diseases who were exposed to anti-TNFα (mostly infliximab,
etanercept, and adalimumab) and 63,308 individuals not exposed.
A 20% improvement in ACR criteria at week 24 --the primary endpoint of the randomized, controlled study--was significantly greater in 284 patients treated with
etanercept monotherapy and in 283 patients treated with combination
etanercept and methotrexate than in 284 patients treated with methotrexate monotherapy (60.9% and 65.0% vs.
In a retrospective study of patients (n: 100) treated with
etanercept or infliximab mainly for rheumatologic conditions including psoriatic arthritis (n: 4) and psoriasis (n: 3), acute bacterial infections were the most common infectious event (
etanercept group: 16.8%, infliximab group: 12.1%).
Four months after cessation of infliximab and 26 months following initial consultation, a twice-weekly 1 mg/kg subcutaneous
etanercept and 0.05% topical desoximetasone regimen was initiated, leading to a dramatic improvement of symptoms within 1 month.
Pharma company Lupin Limited stated on Wednesday that it will commercialise its biosimilar to Enbrel (
etanercept) in partnership with Mylan NV (NASDAQ:MYL).
"The
Etanercept BS is the first biosimilar product containing
etanercept material which is available in Japan.
However, there are a small number of literatures possible that involve tumor necrosis factor-alpha blocking agents (anti-TNF-[alpha]), especially
etanercept, in the development of pulmonary sarcoidosis [2].
Brian Hassett, Steven Vicik, and Brian Fitzpatrick from Pfizer Biotech contended that a particular glycan profile, presented in comparison to different profiles, does not correspond to the historical profile of the reference medicinal product of
etanercept (Enbrel[R]), as it is exposed.
Etanercept, a human recombinant soluble tumor necrosis factor-[alpha] (TNF-[alpha]) receptor protein, is considered to be an effective TNF-[alpha] inhibitor (10).
(4)
Etanercept is the most frequently mentioned agent followed by infliximab and adalimumab.
The confirmatory research, dubbed "The EGALITY Study," found that there was no clinically meaningful difference between Sandoz's biosimilar
etanercept and the original product, Enbrei (which is manufactured by Immunex Corp.