Delving into the Latest Updates on Etanercept biosimilar(Hanwha Chemical (Thailand) Co. Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Fusion protein

Synonyms

Davictrel, Etanercept biosimilar

+ [2]

Target

LTα x TNF-α

Mechanism

LTα inhibitors(Tumor necrosis factor β inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Ankylosing SpondylitisArthritis, PsoriaticRheumatoid Arthritis

Inactive Indication-

Originator Organization

Hanwha Chemical (Thailand) Co., Ltd.

Active Organization

HANWHA SOLUTIONS CORP.

Inactive Organization

Hanwha Chemical (Thailand) Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

(11 Nov 2014),

Ankylosing SpondylitisArthritis, PsoriaticRheumatoid Arthritis

Regulation-

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Gene Sequence

Sequence Code 38320

The sequence is quoted from: *****

OBJECTIVEWe aimed to assess the relative efficacy and safety of etanercept biosimilars and etanercept originators in patients with active rheumatoid arthritis (RA) who showed an inadequate response to methotrexate (MTX).MATERIALS AND METHODSWe performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of etanercept biosimilars vs. etanercept originators in patients with active RA despite treatment with MTX.RESULTSThree RCTs involving 1,200 patients, including 4 types of biologics, were included. Ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that LBEC0101 had a high probability of being the better treatment in terms of the American College of Rheumatology 20 (ACR20) response rate (SUCRA = 0.744), followed by HD203 (SUCRA = 0.457), SB4 (SUCRA = 0.446), and etanercept (SUCRA = 0.352), although no difference in the ACR20 response rate between the biosimilars and etanercept groups was found. Although not statistically significant, there was a difference in the ranking probability of safety based on serious adverse events (SAEs) among interventions. Ranking probability based on SUCRA values indicated that LBEC0101 had the highest probability of being the safest treatment (SUCRA = 0.638), followed by SB4 (SUCRA = 0.495) and HD203 (SUCRA = 0.475), while etanercept had the lowest probability of being the safest treatment (SUCRA = 0.393).CONCLUSIONNo significant difference was found between etanercept biosimilars and etanercept originators in patients with active RA despite treatment with MTX in terms of the ACR20 response rate and SAEs.

01 Jan 2017·Annals of the Rheumatic DiseasesQ1 · MEDICINE

A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study

Q1 · MEDICINE

Article

Author: Shim, Seung-Cheol ; Park, HanYu ; Lee, Sang-Heon ; Ahn, Yongho ; Choi, Chan-Bum ; Park, Yong-Beom ; Park, Won ; Choe, Jung-Yoon ; Kim, Jinseok ; Lee, Shin-Seok ; Lee, So-Ra ; Sung, Yoon-Kyoung ; Bae, Sang-Cheol

ObjectivesTo evaluate equivalence in efficacy for rheumatoid arthritis (RA) and compare the safety of the biosimilar HD203 with innovator etanercept (ETN) plus methotrexate (MTX) (ClinicalTrials.govNCT01270997).MethodsPatients with active RA received 25 mg HD203 or ETN subcutaneously twice-weekly with MTX for 48 weeks in a phase III, multicentre, randomised, double-blind, parallel-group design. The primary end point was the proportion of patients achieving the American College of Rheumatology 20% response (ACR20) at week 24 for per-protocol study completer set (PPS). Secondary end points included ACR response criteria, ACRn, European League against Rheumatism (EULAR) response, change in Disease Activity Score 28 (DAS28), patient-reported outcomes, safety and immunogenicity.ResultsOf the 294 randomised patients (HD203, n=147; ETN, n=147), 233 comprised the 24-week PPS (n=115 and 118, respectively). ACR20 at week 24 was achieved by 83.48% and 81.36% of PPS patients, respectively, demonstrating equivalent efficacy within predefined margins of ±20% (treatment difference 2.12%, 95% CI −7.65% to 11.89%). Outcomes for secondary end points were consistent with the primary efficacy findings. Groups were comparable for overall incidences of treatment-emergent (all-causality) adverse events (AEs) (HD203 113 (76.9%) vs ETN 114 (78.1%) (p=0.804)), adverse drug reactions, serious AEs and discontinuations due to AEs. Few patients (HD203, n=8; ETN, n=3) tested positive for anti-drug antibodies.ConclusionThe study met the primary objective of demonstrating equivalent efficacy of HD203 and ETN. HD203 was well tolerated, with safety comparable with ETN in this population of patients with RA.Trial registration numberNCT01270997; Results.

01 Jan 2017·Annals of the Rheumatic Diseases

Clinical trials of biosimilars should become more similar

Communications

Author: Isaacs, John D ; Kay, Jonathan

Since the approval of the infliximab biosimilar, CT-P13, by the Korean Ministry of Food & Drug Safety (MFDS) on 23 July 2012,1 biosimilars to treat inflammatory diseases have become available to patients in many countries around the world.2 The European Commission (EC) approved CT-P13 on 10 September 2013,3 and, subsequently, it has been granted marketing authorisation by regulatory agencies in many other countries, including the USA. CT-P13 is now marketed in >70 countries worldwide as Remsima, Inflectra and Flammegis.4 Several other biosimilars of tumour necrosis factor (TNF) inhibitors have also received regulatory approval and are commercially available. HD203 was the first etanercept biosimilar granted marketing authorisation by the Korean MFDS on 11 November 2014 and was marketed as Davictrel in South Korea.5 However, because the facility where it was manufactured was sold, its licence could not be retained and it was withdrawn from the market upon the request of its manufacturer on 30 September 2015. Another etanercept biosimilar, SB4, which received approval by the Korean MFDS on 8 September 2015 and by the EC on 14 January 2016, is marketed as Brenzys in South Korea and as Benepali in the European Union (EU) and in the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.5 ,6 SB2, another infliximab biosimilar, was granted marketing authorisation by the Korean MFDS on 4 December 2015 and by the EC on 26 May 2016, and is sold as Renflexis in South Korea and as Flixabi in the EU and EEA member states.5 ,7 In this issue, Bae et al 8 report the results of the phase III clinical trial of HD203 (etanercept biosimilar), Emery and colleagues report the results of the phase III clinical trial of SB4 (etanercept biosimilar)9 and Choe et …

100 Deals associated with Etanercept biosimilar(Hanwha Chemical (Thailand) Co. Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	-	HANWHA SOLUTIONS CORP.	11 Nov 2014
Arthritis, Psoriatic	-	HANWHA SOLUTIONS CORP.	11 Nov 2014
Rheumatoid Arthritis	-	HANWHA SOLUTIONS CORP.	11 Nov 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Discovery	KR	Hanwha Chemical (Thailand) Co., Ltd.	01 Dec 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01270997 (HERA, Pubmed \| Arthritis Rheumatol) Manual	Phase 3	Rheumatoid Arthritis	294	methotrexate+HD203	(iikbgkgpwz) = tqlrosxloe aihalcthcu (glvreqvmbl ) View more	Similar	01 Jan 2017
				methotrexate+etanercept	(iikbgkgpwz) = izkwslbsxi aihalcthcu (glvreqvmbl ) View more
NCT01270997 (EULAR2014)	Phase 3	Rheumatoid Arthritis	294	HD203	(nnevggbkdc) = iessyotizy iwtepvlloc (cbuivjxjjk ) View more	Positive	11 Jun 2014
				Enbrel	(nnevggbkdc) = ajgmwtwlsd iwtepvlloc (cbuivjxjjk ) View more