Delving into the Latest Updates on Adalimumab biosimilar (Sinocelltech Group) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Recombinant human TNF-α monoclonal antibody(Sinocelltech Group), 重组全人源抗肿瘤坏死因子α单抗 (神州细胞工程)

+ [3]

Target

TNF-α

Action

inhibitors

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [3]

Active Indication

Ankylosing SpondylitisCrohn DiseasePlaque psoriasis+ [3]

Inactive Indication-

Originator Organization

Sinocelltech Group Ltd.

Active Organization

Shenzhou Cell Engineering Co. Ltd.

Sinocelltech Group Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (07 Jun 2023),

Ankylosing SpondylitisCrohn DiseasePlaque psoriasis+ [3]

Regulation-

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Structure/Sequence

Sequence Code 26792L

The sequence is quoted from: *****

Sequence Code 88699H

The sequence is quoted from: *****

Author: Wang, Gang ; Guo, Shuping ; Yu, Chen ; Ding, Yangfeng ; Zhang, Furen ; Gu, Jun ; Wang, Yan ; Sun, Qing ; Pang, Xiaowen ; Li, Yuzhen ; Kang, Xiaojing ; Jiang, Xian ; Lu, Qianjin ; Zhang, Chunlei ; Deng, Danqi ; Tao, Juan ; Song, Zhiqiang ; Zhao, Yi ; Jin, Hongzhong ; Wang, Jieying ; Pan, Weili ; Yang, Qinping ; Kuang, Yehong ; Xie, Liangzhi ; Li, Yumei

INTRODUCTIONThis phase III study aimed to compare the efficacy, safety, and immunogenicity of SCT630 with the reference adalimumab.METHODSA total of 367 Chinese patients with moderate-to-severe plaque psoriasis were randomly assigned to receive 80 mg of SCT630 or adalimumab subcutaneously at week 1, 40 mg at week 2, then 40 mg biweekly. At week 16, those with 50 % or more improvement in psoriasis area and severity index (PASI) were eligible to enter an extension period up to week 52. Patients on SCT630 continued the same treatment, whereas patients receiving adalimumab were re-randomized at a ratio of 1:1 to adalimumab or SCT630 group. The primary endpoint was percentage improvement in PASI at week 16. Other endpoints included PASI 50/75/90/100, Physician's Global Assessment, Dermatology Life Quality Index, safety, and immunogenicity.RESULTSPASI improvement at week 16 was 85.07 % for SCT630 and 84.82 % for adalimumab. The mean difference (3.10 %, 95 % CI: -1.875 %, 8.066 %) was within the equivalence interval. Other efficacy endpoints, safety and immunogenicity profiles were similar across the two groups. There were no safety or immunogenicity difference between switched/continued groups.CONCLUSIONThis phase III study demonstrated the equivalences in efficacy, safety and immunogenicity of SCT630 to adalimumab in patients with moderate to severe psoriasis.

01 May 2022·International ImmunopharmacologyQ2 · MEDICINE

Phase I, randomized, double-blind, single-dose study to assess the pharmacokinetics, safety, and immunogenicity of the proposed biosimilar SCT630 and adalimumab in healthy Chinese subjects

Q2 · MEDICINE

Article

Author: Lei, Chunpu ; Wang, Xinghe ; Wang, Yu ; Liu, Ying ; Liu, Ju ; Bai, Haihong ; Li, Yinjuan ; Liu, Long ; Qi, Lu ; Li, Yan ; Zhang, Wei ; Li, Pu ; Xie, Liangzhi

We aimed to compare the pharmacokinetics, safety, and immunogenicity of the adalimumab biosimilar SCT630 with those of its reference (adalimumab, Humira®). This study involved a randomized, double-blind, parallel-controlled design; healthy subjects (N = 146) were randomly distributed into two groups to receive a single-dose subcutaneous injection of 40 mg SCT630 or 40 mg adalimumab, with a 71-day follow up. The bioequivalence of the primary pharmacokinetic parameters (AUC₀-t) and maximum observed serum concentration (C_max) between SCT630 and adalimumab were the primary endpoints; safety and immunogenicity of SCT630 compared with those of adalimumab were the secondary endpoints. The geometric mean C_max ratio of SCT630 to adalimumab and its 90% confidence interval (CI) were 116.02% and 108.66%-123.88%, AUC₀-t ratio and 90% CI were 109.47% and 99.80%-120.08%, and AUC_0-∞ ratio and 90% CI were 109.24% and 99.80%-120.78%. These PK parameters fulfilled the equivalence criterion of 80.00%-125.00%. Treatment-emergent adverse events (TEAEs) occurred in 62 (84.9%) and 61 (83.6%) subjects; mild and moderate drug-related TEAEs were observed in 60 (82.2%) and 59 (80.8%) subjects in the adalimumab and SCT630 groups, respectively. On day 71, 69 (95.8%) subjects in the adalimumab group and 66 (93%) in the SCT630 group reported positive anti-drug antibodies. Among them, 15 (21.7%) and 11 (16.7%) subjects showed positive neutralizing antibodies, with no significant difference. SCT630 was well tolerated and demonstrated PK and safety profiles similar to adalimumab. The profiles support the initiation of further confirmatory study to demonstrate the clinical similarity of SCT630 to adalimumab.

100 Deals associated with Adalimumab biosimilar (Sinocelltech Group)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	China	Sinocelltech Group Ltd.	07 Jun 2023
Ankylosing Spondylitis	China	Shenzhou Cell Engineering Co. Ltd.	07 Jun 2023
Crohn Disease	China	Shenzhou Cell Engineering Co. Ltd.	07 Jun 2023
Crohn Disease	China	Sinocelltech Group Ltd.	07 Jun 2023
Plaque psoriasis	China	Sinocelltech Group Ltd.	07 Jun 2023
Polyarticular Juvenile Idiopathic Arthritis	China	Shenzhou Cell Engineering Co. Ltd.	07 Jun 2023
Polyarticular Juvenile Idiopathic Arthritis	China	Sinocelltech Group Ltd.	07 Jun 2023
Rheumatoid Arthritis	China	Sinocelltech Group Ltd.	07 Jun 2023
Rheumatoid Arthritis	China	Shenzhou Cell Engineering Co. Ltd.	07 Jun 2023
Uveitis	China	Sinocelltech Group Ltd.	07 Jun 2023
Uveitis	China	Shenzhou Cell Engineering Co. Ltd.	07 Jun 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03927352 (Pubmed) Manual	Phase 3	Plaque psoriasis	367	SCT630	(lbnvexajtc) = bqqzyxtrxt zoliyctieq (sfrxdylizx )	Similar	17 Sep 2022
				adalimumab	(lbnvexajtc) = zgfrfxjixc zoliyctieq (sfrxdylizx )

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Biosimilar

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