Delving into the Latest Updates on Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.) with Synapse

Overview

Basic Info

Drug Type

Interferons, Biosimilar

Synonyms

Peg IFN α-2b, PegiHep, Peginterferon alpha 2b biosimilar

+ [2]

Target

IFNAR

Action

agonists, stimulants, inducers

Mechanism

IFNAR agonists(Interferon alpha/beta receptor agonists), Immunostimulants, Innate antiviral immune response inducers

Therapeutic Areas

Infectious DiseasesDigestive System DisordersSkin and Musculoskeletal Diseases+ [1]

Active Indication

Condylomata AcuminataHepatitis BHepatitis C

Inactive Indication

COVID-19

Originator Organization

Zydus Cadila Healthcare Ltd.

Active Organization

Zydus Cadila Healthcare Ltd.

Inactive Organization

Zydus Lifesciences Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (01 Jan 2014),

Condylomata AcuminataHepatitis BHepatitis C

Regulation-

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Structure/Sequence

Sequence Code 26333714

The sequence is quoted from: *****

Aims/Background Hepatitis B virus (HBV) infection poses a challenge to global healthcare. Peginterferon alfa-2b (PEG-IFNα-2b) is an effective treatment for HBV infection. This study aimed to explore the efficacy of PEG-IFNα-2b combined with entecavir in the treatment of HBV infection, its effect on liver function and immune factors, and the risk factors affecting the prognosis of patients with HBV infection. Methods The clinical data of 184 patients with HBV infection who were treated at Jinhua Central Hospital from January 2021 to January 2024 were collected for retrospective analysis. Patients were divided into a control group (not receiving antiviral treatment, n = 34), a standard treatment group (receiving entecavir, n = 85), and a combination treatment group (PEG-IFNα-2b and entecavir, n = 65) according to the treatment approach. Treatment efficacy, liver function indicators (albumin [ALB], alanine aminotransferase [ALT], and aspartate aminotransferase [AST]), immune factor indexes (tumour necrosis factor alpha [TNF-α] and interferon gamma [IFN-γ]), hepatitis B surface antigen [HBsAg] and HBV DNA levels were compared among the three groups. All patients were followed up after treatment. According to their prognosis, the patients were divided into good prognosis group (n = 118) and poor prognosis group (n = 66). Logistic regression analysis was performed to explore the risk factors affecting the prognosis of HBV patients. Results The efficacy in the combination treatment group was higher (92.31%) than that in the control group (8.82%) and the standard treatment group (78.82%) (p < 0.05). After treatment, the HBsAg and HBV DNA levels were decreased in the standard treatment and combination treatment groups (p < 0.05). Compared with the control and standard treatment groups, the combination treatment group exhibited significantly lower HBsAg and HBV DNA levels after treatment (p < 0.05). Besides, the combination treatment group had lower ALT and AST levels (p < 0.05), and higher ALB level (p < 0.05), than the control and standard treatment groups after treatment. Compared with the control and standard treatment groups, the combination treatment group demonstrated decreased TNF-α level and higher IFN-γ level after treatment (p < 0.05). Multivariate logistic regression analysis identified family medical history as the risk factor affecting the prognosis of patients with HBV infection (p = 0.001, odds ratio [OR] = 3.614, 95% confidence interval [CI]: 1.685–7.750) and therapy regimen as the protective factor (p = 0.029, OR = 0.135, 95% CI: 0.022–0.815). Conclusion The PEG-IFNα-2b combination therapy in patients with HBV infection significantly improves the clinical treatment efficacy, liver function, and immune factors. In addition, this study found that therapy regimen and family medical history are independent factors affecting the prognosis of HBV infection.

01 Apr 2025·Hepatology International

Predictive model for HBsAg clearance rate in chronic hepatitis B patients treated with pegylated interferon α-2b for 48 weeks

Article

Author: Geng, Jiawei ; Wu, Xiaoping ; Gao, Xiaohong ; Guo, Ying ; Wang, Tao ; Kong, Nan ; Qu, Lihong ; Shang, Jia ; Zhang, Wenhong ; You, Ruirui ; Zhang, Qiran ; Zhang, Fengdi ; Tan, Zhili

AbstractBackground and AimsChronic hepatitis B (CHB) is a major global health concern. This study aims to investigate the factors influencing hepatitis B surface antigen (HBsAg) clearance in CHB patients treated with pegylated interferon α-2b (Peg-IFNα-2b) for 48 weeks and to establish a predictive model.MethodsThis analysis is based on the “OASIS” project, a prospective real-world multicenter study in China. We included CHB patients who completed 48 weeks of Peg-IFNα-2b treatment. Patients were randomly assigned to a training set and a validation set in a ratio of approximately 4:1 by spss 26.0, and were divided into clearance and non-clearance groups based on HBsAg status at 48 weeks. Clinical data were analyzed using SPSS 26.0, employing chi-square tests for categorical data and Mann–Whitney U tests for continuous variables. Significant factors (p < 0.05) were incorporated into a binary logistic regression model to identify independent predictors of HBsAg clearance. The predictive model’s performance was evaluated using ROC curve analysis.ResultsWe included 868 subjects, divided into the clearance group (187 cases) and the non-clearance group (681 cases). They were randomly assigned to a training set (702 cases) and a validation set (166 cases). Key predictors included female gender (OR = 1.879), lower baseline HBsAg levels (OR = 0.371), and cirrhosis (OR = 0.438). The final predictive model was:Logit(P) = 0.92 + Gender (Female) * 0.66 - HBsAg (log) * 0.96 - Cirrhosis * 0.88. ROC analysis showed an AUC of 0.80 for the training set and 0.82 for the validation set, indicating good predictive performance.ConclusionGender, baseline HBsAg levels, and cirrhosis are significant predictors of HBsAg clearance in CHB patients after 48 weeks of Peg-IFNα-2b therapy. The developed predictive model demonstrates high accuracy and potential clinical utility.

01 Feb 2025·Pediatric Infectious Disease Journal

Dynamic Changes of Growth and Thyroid Function in Young Children With Chronic Hepatitis B Treated With Peginterferon Monotherapy

Article

Author: Hu, Rong ; Zeng, Yilan ; He, Qiufeng ; Huang, Liang ; Deng, Yang ; Duan, Fangfang ; Chen, Zhili ; Mao, Chuangjie ; Yang, Song ; Cheng, Jun

Background:Peginterferon (PegIFN) has shown promising results in the treatment of chronic hepatitis B (CHB). This study aimed to evaluate the effects of PegIFN α-2b on growth and thyroid function in young children with CHB.Methods:A retrospective study was performed by extracting clinical data from children with CHB who received PegIFN α-2b monotherapy at the Public Health Clinical Center of Chengdu between June 2017 and December 2020. Mean, SD, independent samples t test and 1-way repeated analysis of variance were used to evaluate relevant data.Results:A total of 62 children were included in this study. Overall, significant differences were observed in the weight-for-age z score (WAZ), height-for-age z score (HAZ) and body mass index-for-age z score (BAZ) at different time points (P < 0.001). WAZ, HAZ and BAZ were not affected by PegIFN α-2b at 24 weeks of treatment (all P > 0.05). WAZ, HAZ and BAZ at the end of treatment and 48 weeks after treatment; WAZ at 96 weeks after treatment were lower than baseline levels (all P < 0.05). No statistical differences were found in HAZ and BAZ at 96 weeks after treatment compared with baseline. Thyroid dysfunction developed in 17.7% of children during the treatment. Thyroid dysfunction was transient and had no effect on growth.Conclusions:PegIFN α-2b has inhibitory effects on growth and can increase the incidence of thyroid dysfunction in young children with CHB. These effects are generally reversible with the cessation of therapy, although WAZ had not returned to baseline after 96 weeks of observation.

100 Deals associated with Peginterferon alpha-2b biosimilar(Zydus Cadila Healthcare Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB10	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Condylomata Acuminata	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014
Hepatitis B	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014
Hepatitis C	Japan	Zydus Cadila Healthcare Ltd.	01 Jan 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	Mexico	Zydus Lifesciences Ltd.	11 Aug 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2024	Not Applicable	Polycythemia Vera \| Thrombocythemia, Essential	81	Peg-IFN-α-2b	(jkhzqezmsg) = zwrxaombar xzoctheouf (gjugaxidss )	Positive	14 May 2024
ASCO_GI2018	Not Applicable	Unresectable Intrahepatic Cholangiocarcinoma	21	Hepatic arterial infusion chemotherapy (HAIC) using 5-fluorouracil and subcutaneous PEG-IFN α-2b	(xjvzdyorlp) = All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment related deaths were not observed. kmxziqrdzq (nwpemmrsmf )	Positive	26 Feb 2018
ASCO_GI2015	Not Applicable	Advanced Hepatocellular Carcinoma	59	Combined hepatic arterial infusion chemotherapy of 5-fluorouracil (5-FU) and systemic pegylated interferon (PEG-IFN) α-2b	rcpsyewtph(pocobazkms) = tlbkavwwvk pwngvkmsoh (euzafqsgik ) View more	-	20 Jan 2015
IAS2007	Not Applicable	HIV Infections \| Hepatitis C	-	Standard weekly PEG-IFN	(wpcmzlmwdo) = The adverse events were similar in both arms ekcaahsqrp (llheaexagh )	Positive	01 Jan 2007
IAS2007	Not Applicable	HIV Infections \| Hepatitis C	-	Twice weekly Peg-IFN		Positive	01 Jan 2007

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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