Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration: A Randomized, Multicentre, Controlled Trial

A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class. Moreover, according to STRIDE 2 recommendations and CALM study, optimize patients based solely on lack of biological remission (CRP, calprotectin) can be discuss. If CALM study has showed that the intervention arm based on regular monitoring fecal calprotectin, CRP and/or CDAI to optimize patients under adalimumab was significantly associated to an increase rate of mucosal healing that the standard of care strategy based on only clinical activity, TDM was not available to guide drug optimization strategy.

Start Date01 Oct 2024

Sponsor / Collaborator

Centre Hospitalier Universitaire de Saint-Etienne

[+1]

NCT02722044 / CompletedPhase 3

An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)

Start Date01 Apr 2016

Sponsor / Collaborator

Momenta Pharmaceuticals, Inc.

NCT02675023 / CompletedPhase 1

A Randomized, Open-label, Two-arm, Parallel Group, Single Dose Study to Assess the Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects

This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.

Start Date01 Jan 2016

Sponsor / Collaborator

Momenta Pharmaceuticals, Inc.

100 Clinical Results associated with Adalimumab biosimilar(Momenta Pharmaceuticals, Inc.)

100 Translational Medicine associated with Adalimumab biosimilar(Momenta Pharmaceuticals, Inc.)

100 Patents (Medical) associated with Adalimumab biosimilar(Momenta Pharmaceuticals, Inc.)

Literatures (Medical) associated with Adalimumab biosimilar(Momenta Pharmaceuticals, Inc.)

01 Jan 2023·Frontiers in pharmacology

Efficacy and safety of adalimumab biosimilar (HS016) in inflammatory bowel disease from the real-world study.

Article

Author: Li, Xiaofei ; Zhou, He ; Wu, Tong ; Li, Ruixia ; Yang, Gang ; Shi, Yanting ; Liang, Jie ; Wang, Fang

Objective: Adalimumab (ADA) is an effective treatment for inflammatory bowel disease (IBD), both ulcerative colitis (UC) and Crohn's disease (CD). The equal effect between the original ADA and biosimilars from Europe and the United States has been shown. However, the biosimilar of ADA is different in China. The effectiveness and safety data of ADA biosimilar (HS016) in China have yet to be discovered. Patients and methods: 91 patients (75 CD, 16 UC) received HS016 treatment and were enrolled in this study. Therapeutic response and safety profiles were analyzed. Therapeutic drug monitoring (TDM) was also carried out among nonresponse patients. After being considered as "nonresponse" (after three or 6 months of treatment), 20 patients' serum TNFα concentrations were measured and correlated to their disease severity. Results: Among active CD patients (n = 61), 75.4% (46/61) at 12 w, 73.8% (45/61) at 26 w, 50.8% (31/61) at 52 w achieved the clinical response, respectively; 55.7% (34/61) at 12 w, 65.6% (40/61) at 26 w, and 45.9% (28/61) at 52 w achieved clinical remission. The maintained remission rates of CD (n = 14) in clinical remission were 100% (14/14) at 12 w, 78.6% (11/14) at 26 w, and 63.6% (7/11) at 52 w, respectively. Among active UC patients, 37.5% (6/16) at 12 w and 50% (8/16) at 26 w achieved clinical response. Total adverse event rates were 5.5% (5/91) during 52-week visits. Due to the inadequate serum drug concentration, 30.4% (7/23) of patients had poor clinical responses. Elevations of serum anti-drug antibodies occurred in one additional patient (4.3%). Conclusion: ADA biosimilar HS016 had good efficacy and safety in Chinese IBD patients.

01 Jun 2020·BioDrugs

Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial

Article

Author: Liu, Xiumei ; Xu, Jianhua ; Liu, Yi ; Jiang, Lindi ; Huang, Cibo ; Li, Jingyang ; He, Lan ; Huang, Anbin ; He, Dongyi ; Dong, Lingli ; Li, Mengtao ; Tao, Yi ; Liu, Xiangyuan ; Su, Jinmei ; Liu, Huaxiang ; Zhang, Zhuoli ; Zhao, Dongbao ; Chen, Haiying ; Wang, Yanyan ; Zeng, Xiaofeng ; Li, Tianwang ; Zuo, Xiaoxia ; Wan, Weiguo ; Zhang, Zhiyi ; Lu, Xin ; Xu, Jian ; Li, Xiaofeng ; Wei, Wei ; Wu, Huaxiang ; Li, Fen

OBJECTIVEThe aim of this study was to evaluate the efficacy and safety of the biosimilar candidate of adalimumab (HS016) compared with adalimumab (Humira) for the treatment of active ankylosing spondylitis.METHODSA multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial was conducted at 28 locations in China. Patients with active ankylosing spondylitis were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 or adalimumab every other week for 24 weeks. The primary endpoint was to achieve at least a 20% improvement (ASAS20) in patients at 24 weeks according to the Assessment of Spondyloarthritis International Society criteria. The secondary endpoint included other efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters.RESULTSFollowing the random assignment of 648 patients into HS016 (n = 416) and adalimumab (n = 232) groups, no significant difference was found in the ASAS20 response rates at 24 weeks between the HS016 (364/416, 87.5%) and adalimumab (209/232, 90.1%) treatments and the difference between the response rates (- 2.59%; 90% confidence interval [CI] - 6.77 to 1.60) was within the predefined equivalence margin (± 15%). There were also no significant differences when the secondary endpoints were compared (all p > 0.05). Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate. Only nine severe cases were found, including seven within the HS016 group, three (0.7%) of which were tuberculosis cases. Plasma concentrations of HS016 and adalimumab from weeks 12 to 14 were similar during the steady-state period and steady-state maximal concentration (C_max,ss) was equivalent for HS016 (7356.6 ng/mL) and adalimumab (7600.3 ng/mL). The accumulated proportion of patients with positive human anti-human antibodies (HAHAs) at week 24 was 326/412 (79.1%) in the HS016 group and 183/229 (79.9%) in the adalimumab group (p > 0.05), while the accumulated proportion of patients with positive neutralizing antibody (NAb) tests were 72/412 (17.5%) in the HS016 group and 43/229 (18.8%) in the adalimumab group (p > 0.05).CONCLUSIONHS016 resembled adalimumab in efficacy and safety over the 24-week treatment period.TRIAL REGISTRATION NUMBERChiCTR1900022520.

01 Feb 2018·Pharmacology Research & PerspectivesQ4 · MEDICINE

Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects

Q4 · MEDICINE

ArticleOA

Author: Huntenburg, Carolyn ; Reeve, Russell ; Doralt, Jennifer ; Rosano, Molly ; Alai‐Safar, Mehrshid ; Rhyne, Paul W. ; Ganguly, Tanmoy ; Caminis, John ; Weilert, Doris ; Goel, Niti ; Darne, Siddhesh ; Mant, Tim ; Chance, Kamali ; Hillson, Jan ; Roach, James ; Palmer, Donna ; Pavlova, Borislava G.

AbstractThe aims of this randomized, double‐blind, three‐arm, single‐dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as “M923”) to each of 2 reference products, and to assess M923's safety and immunogenicity. Primary PK endpoints were maximum observed concentration (Cmax), area under the curve (AUC) from time 0 extrapolated to infinity (AUC0‐inf), and AUC from time 0 to 336 hours (AUC0‐336). Secondary endpoints included safety and immunogenicity assessments. Healthy subjects were randomized 1:1:1 to receive a 40‐mg dose of M923 (n = 107); adalimumab US Humira (n = 105), hereafter referred to as “US Humira”; or adalimumab EU Humira (n = 103), hereafter referred to as “EU Humira.” PK equivalence was demonstrated for all primary PK endpoints. Geometric least squares means ratios (GMRs) for Cmax, AUC0‐inf, and AUC0‐336 were 99.4, 100.9, and 100.5, respectively, between the M923 and EU Humira arms and 102.6, 104.2, and 102.9 between the M923 and US Humira arms. The 90% confidence intervals of the GMRs for all PK endpoints were within prespecified confidence bounds of 80%‐125%. Adverse event rates were similar across the M923 (47.7%), US Humira (50.9%), and EU Humira (53.3%) arms and were generally mild (73.7%) or moderate (22.0%). The proportion of subjects with a confirmed antidrug antibody (ADA) response was similar across study arms. This study demonstrated bioequivalent PK among M923, US Humira, and EU Humira and demonstrated that the PK parameters were consistent with similar safety and tolerability profile and ADA response rates.

News (Medical) associated with Adalimumab biosimilar(Momenta Pharmaceuticals, Inc.)

11 Oct 2023

·www.globenewswire.com

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology

Phase 3 study for SB17, Samsung Bioepis’ ustekinumab biosimilar candidate, demonstrates biosimilarity with reference ustekinumab through equivalent efficacy and comparable safety and pharmacokinetics (PK) up to Week 28Also presents 4-year follow-up data of efficacy and safety of adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from British Association of Dermatologics and Immunomodulators Register (BADBIR) INCHEON, South Korea, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd.’s new data on its ustekinumab biosimilar candidate SB17 and four-year follow-up data for its adalimumab biosimilar SB5 are presented today at the European Academy of Dermatology and Venereology (EADV) Congress being held from October 11 to 14 in Berlin, Germany. The Phase 3 study for SB17, a proposed biosimilar to Stelara1 (ustekinumab), was a randomized double-blind study to compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB17 with reference ustekinumab (UST) in patients with moderate to severe plaque psoriasis. The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28. The study met the primary endpoint - percent change from baseline in Psoriasis Area Severity Index (PASI) at Week 12, with an adjusted difference of -0.6 (95% confidence interval (CI): [−3.780 to 2.579], per-protocol set), being fully contained within the pre-defined equivalence margin. Other efficacy and safety endpoints were comparable up to Week 28. SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab). In September, the company announced a partnership deal with Sandoz to commercialize SB17 in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK). Samsung Bioepis also shared 4-year follow-up data of effectiveness and safety of its adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) - a UK and Ireland registry that assesses the long-term safety of biologic treatments for psoriasis, in which Samsung Bioepis has participated since May 2016. The 4-year follow-up data of eligible patients treated with SB5 between June 2019 and August 2022 from BADBIR indicated that SB5 can be started or transitioned from reference adalimumab in patients with moderate-to-severe psoriasis with an effectiveness and safety profile. “Presenting two abstracts at EADV demonstrates our continuous commitment to providing clinically proven biosimilars in terms of efficacy, safety and immunogenicity to patients who need them and making physicians and patients confident on use of biosimilar in real setting,” said Hyejin Kim, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis. SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI™ as a biosimilar to HUMIRA2. In Europe, IMRALDI™ is commercialized by Biogen along with BENEPALI™ (etanercept; SB4) and FLIXABI™ (infliximab; SB2). Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe. Details of the Samsung Bioepis’ abstracts are as follows: Abstract TitleAbstract DetailsA Randomised, Double-blind, Phase III Study Demonstrating Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque PsoriasisAbstract ID: 1320Poster ID: P0720Poster Open Date/Time: Oct 11, 9:00 AMAuthors: Steven Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Elżbieta Kłujszo, Dmytro Rekalov, Lidia Rajzer, Jiyoon Lee, Minkyung Lee, and Young Hee RhoLong-Term Real-World Data of SB5 (Adalimumab Biosimilar) Treatment in Patients with Moderate-to-Severe Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR))Abstract ID: 4782 Poster ID: P2569 Poster Open Date/Time: Oct 11, 9:00 AMAuthors: Giampiero Girolomoni, Steven Feldman, Alexander Egeberg, Luis Puig Sanz, Hojung Jung, Younjin Park, Younju Lee About Samsung Bioepis Co., Ltd.Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn. References:___________________ 1 Stelara is a trademark of Janssen Pharmaceuticals. 2 Humira is a trademark of AbbVie Biotechnology Ltd. 3 2022 Q3 Biogen Earnings presentation.

Phase 3Clinical ResultDrug ApprovalLicense out/in

28 Sep 2016

·www.pharmatimes.com

Shire steps away from biosimilars

Shire has handed back rights to the two biosimilars it acquired through its recent purchase of Baxalta, retaining its focus on the development of drugs for rare diseases. The UK-based group is returning global development and commercialisation rights to M923, a proposed biosimilar of Humira (adalimumab), to US group Momenta Pharmaceuticals, but will continue to fund the programme for 12 months as per the original deal with Baxalta. "We view Shire's decision as a significant opportunity for us to capture additional value from this program for the Company and its shareholders. We remain very excited about the potential for our biosimilar HUMIRA candidate and look forward to reporting top-line results of the current Phase III trial of M923 in late 2016," said Momenta's president and chief executive, commenting on the move. US biotech Coherus BioSciences has also regained from Shire all development and commercial rights previously licensed for CHS-0214 etanercept, a biosimilar candidate to Enbrel, for Europe, Canada, Brazil, the Middle East and other territories. The drug has successfully completed two Phase III studies, in chronic plaque psoriasis and rheumatoid arthritis, data from which will support its European marketing application, planned for the fourth quarter of this year. "These reacquired geographical rights fit well with our existing US CHS-0214 rights, and we now have the opportunity to license throughout Europe, US and other key commercial geographies two complimentary Anti-TNF assets - CHS-0214, an Enbrel biosimilar candidate and CHS-1420, a Humira biosimilar candidate".

Biosimilar

100 Deals associated with Adalimumab biosimilar(Momenta Pharmaceuticals, Inc.)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 3	SK	Momenta Pharmaceuticals, Inc.	01 Sep 2015
Plaque psoriasis	Phase 3	PL	Momenta Pharmaceuticals, Inc.	01 Sep 2015
Plaque psoriasis	Phase 3	BG	Momenta Pharmaceuticals, Inc.	01 Sep 2015
Plaque psoriasis	Phase 3	US	Momenta Pharmaceuticals, Inc.	01 Sep 2015
Plaque psoriasis	Phase 3	LV	Momenta Pharmaceuticals, Inc.	01 Sep 2015
Plaque psoriasis	Phase 3	CZ	Momenta Pharmaceuticals, Inc.	01 Sep 2015
Rheumatoid Arthritis	Phase 3	-	Shire Pharmaceuticals Services Ltd.	-
Plaque psoriasis	Phase 1	EE	Momenta Pharmaceuticals, Inc.	01 Sep 2015
Rheumatoid Arthritis	Phase 1	-	Shire Pharmaceuticals Services Ltd.	-
Plaque psoriasis	Discovery	CA	Momenta Pharmaceuticals, Inc.	01 Sep 2015

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04988308 (LYRA, CTgov)	Phase 2	Hidradenitis Suppurativa	151	Placebo (Part 1: Placebo (Week 0-16))	ulwnsewnej(qkpdmvutcr) = zrgkguimum ddalgrsqqz (cwyskusiba, uvxuiittuo - ngbblkfezb) View more	-	13 Nov 2023
				Bermekimab (Part 1: Bermekimab (Week 0-16))	ulwnsewnej(qkpdmvutcr) = btcddpxton ddalgrsqqz (cwyskusiba, lmtniunroz - mqysvqjqjw) View more
NCT03464136 (SEAVUE, CTgov)	Phase 3	Crohn Disease	386	Adalimumab (Adalimumab)	eddsxgfqki(vfdjvmllfu) = rqzbidmjlw swsnrcaycx (ipaxgjrkph, jvmaicehsm - xepgyqbplg) View more	-	11 Jan 2022
				Ustekinumab (Ustekinumab)	eddsxgfqki(vfdjvmllfu) = ndydzyvlmb swsnrcaycx (ipaxgjrkph, ugjtylzdjk - yeogalgimp) View more
VARSITY (UEGW2020)	Not Applicable	Colitis, Ulcerative	769	Vedolizumab	(sxmkfhmhpw) = grwjcpxjkw oejtyamapq (sifdluevsj ) View more	Positive	01 Oct 2020
				Adalimumab	(sxmkfhmhpw) = rlvtizfslm oejtyamapq (sifdluevsj ) View more
UEGW	Phase 3	Colitis, Ulcerative Maintenance	-	Ustekinumab	(txpssibrlf): OR = 1.89 (95% CI, 0.83 - 4.3), P-Value = 93.52% View more	Positive	21 Oct 2019
				Infliximab
NCT02722044 (CTgov)	Phase 3	Rheumatoid Arthritis	33	M923	kyxsvolpwv(bxeadmraot) = mcfobfract eascjoczmy (agnuaqeaej, tfsoqaadwp - eycmlsooxn) View more	-	01 May 2018
UEGW	Not Applicable	Crohn Disease	-	Ustekinumab	(hiqqsrsgja) = muttvitjup mwjbxvalwy (ufsmrtwuqq ) View more	-	01 Oct 2017
				Adalimumab	(hiqqsrsgja) = urxtrfuemq mwjbxvalwy (ufsmrtwuqq ) View more
NCT02019472 (SIRROUND-H, CTgov)	Phase 3	Rheumatoid Arthritis	559	Adalimumab (Adalimumab 40 mg)	stbojsusyl(zjodxktant) = yzgwmhpcuh mtrorlfqwz (ejzkxlymdx, iqbvfspqev - bvqyumojfb) View more	-	14 Sep 2017
				Sirukumab (Sirukumab 50 mg)	stbojsusyl(zjodxktant) = yxqxxbwfco mtrorlfqwz (ejzkxlymdx, dxczyuqnza - ulhmdqgosz) View more

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