Delving into the Latest Updates on Epoetin beta biosimilar(Cinnagen) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Beta erythropoietin, CinnaPoietin, Epoetin beta biosimilar

+ [2]

Target

EPO receptor

Action

agonists

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Anemia

Inactive Indication

Anemia in chronic kidney diseaseKidney Failure, Chronic

Originator Organization

CinnaGen Co.

Active Organization

CinnaGen Co.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

India (01 Jan 2013),

Anemia

Regulation-

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Structure/Sequence

Sequence Code 8988

The sequence is quoted from: *****

A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority Clinical Trial to Determine the Non Inferior Therapeutic Efficacy and Safety Between CinnaPoietin® (Beta Erythropoietin) and Eprex® (Epoetin Alpha) on the Treatment of Anemia in ESRD Hemodialysis Patients

This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of anemia in 156 End-Stage Renal Disease hemodialysis patients. 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-week period. Administration dose for patients who are treated with erythropoietin is the similar dose of the previously administered amount (IV or SC without any change). After then, dose adjustment will be made based on patients' response. The primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The secondary objectives of this study are further comparison and evaluation of efficacy along with safety between CinnaPoietin® and Eprex®.

Start Date22 Jun 2016

Sponsor / Collaborator

CinnaGen Co.

100 Clinical Results associated with Epoetin beta biosimilar(Cinnagen)

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100 Translational Medicine associated with Epoetin beta biosimilar(Cinnagen)

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100 Patents (Medical) associated with Epoetin beta biosimilar(Cinnagen)

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8

Literatures (Medical) associated with Epoetin beta biosimilar(Cinnagen)

07 Nov 2023·Advances in Pharmacological and Pharmaceutical Sciences

Drug Utilization Evaluation of Erythropoietin at a Referral Teaching Hospital in Iran

Article

Author: Rasekh, Hanieh ; Karimian, Ava ; Vazin, Afsaneh ; Shabani-Borujeni, Mojtaba ; Karimzadeh, Iman

Objectives. Drug utilization evaluation (DUE) studies aim to survey the appropriateness of drug use. DUE is an executive approach used to improve the use of medications as well as reduce the cost of treatment, ensure drug adequacy, and improve patient safety. The aim of this study was to evaluate the pattern of erythropoietin use, according to standard guidelines, in patients admitted to Namazi Hospital in Shiraz, Iran. Methods. In this descriptive, retrospective study, 230 patients were assessed. All patients who were hospitalized in different wards of Namazi Hospital, affiliated to Shiraz University of Medical Sciences, and received at least three doses of erythropoietin from September 2019 to March 2020 participated in this study. The following standard indicators of erythropoietin use were evaluated through reviewing medical charts of the cohort: drug dose, dosing intervals, route of administration, indication, monitoring of laboratory parameters, drug dose adjustment based on the response rate as well as target hemoglobin ≥12 g/dl, attention to major drug interactions, and administration of injectable or oral iron supplementation during treatment. Results. Most (65.2%) of the participants were male. The mean ± SD age of the patients was 47.55 ± 22.71 years. More than half (51.3%) of the included subjects were hospitalized in the nephrology ward. PDpoetin® and Cinnapoietin® were given to 52.6% and 47.4% of the study participants, respectively. Treatment of anemia due to chronic kidney disease was the most frequent indication of erythropoietin. The time interval of erythropoietin administration was three times a week for 68.3% of the patients. The most frequently administered weekly dose of erythropoietin was 12,000 units. The weekly dose, dose interval, and route of administration of erythropoietin were appropriate in 52.6%, 77.4%, and 100% of the patients, respectively. Dose adjustment based on the response rate, attention to major drug interactions as well as absolute-relative contraindications, and attention to the target hemoglobin ≥12 g/dl to decide whether or not to continue treatment were based on standard guideline in 98.1%, 98.7%, and 93% of the patients, respectively. The sum indexes of erythropoietin use were in line with standard guidelines in 75.84% of the cases. Conclusion. According to our results, in the setting of erythropoietin use in hospitals, physicians need more attention and education in areas such as selecting the proper dose of medication, correct indication of the drug, temporal arrangement of monitoring laboratory items, and the patient’s need for iron supplements.

01 Jan 2018·American Journal of NephrologyQ3 · MEDICINE

Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients

Q3 · MEDICINE

Article

Author: Nasiri, Amir Ahmad ; Pourfarziani, Vahid ; Ossareh, Shahrzad ; Ezzatzadegan Jahromi, Shahrokh ; Amini, Somayeh ; Sanadgol, Hooshang ; Abbasi, Mohammad Reza ; Shahvaroughi Farahani, Arshia ; Azmandian, Jalal

Background: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. Methods: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10–12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. Results: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10–12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. Conclusion: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).

01 Jan 2013·Nefrologia : publicacion oficial de la Sociedad Espanola NefrologiaQ4 · MEDICINE

The pharmacokinetics of recombinant human erythropoietin in Balkan endemic nephropathy patients.

Q4 · MEDICINE

Article

Author: Ljubica Djukanović ; Nenad Petković ; Višnja Ležaić ; Sanja Simić-Ogrizović ; Branislava Miljković ; Katarina Vučićević ; Vesna Pejovic ; Ivko Marić

BACKGROUNDBalkan endemic nephropathy (BEN) hemodialysis patients require a higher dose of recombinant human erythropoietin for maintaining target hemoglobin level than patients with other kidney diseases.OBJECTIVESComparison of the pharmacokinetics of beta-erythropoietin given subcutaneously to hemodialysis patients with BEN or other kidney diseases (non-BEN).METHODSRecombinant human erythropoietin (75 U/kg) was administered subcutaneously to 10 BEN and 14 non-BEN hemodialysis patients. The predose plasma level of erythropoietin (Epo) was subtracted from all postdose levels. The relevant pharmacokinetic parameters were calculated after noncompartmental pharmacokinetic analysis using Kinetica software (Thermo Scientific, ver.5.0).RESULTSAlthough basal plasma Epo concentration was similar in BEN (20.1 ± 10.3 U/L) and non-BEN (15.1 ± 8.1 U/L; p=.1964) patients, there were significant differences between the groups for elimination rate constant (0.016 ± 0.006 vs 0.026 ± 0.011 hr⁻¹; p=.020) and elimination half-life (50.24 ± 19.12 vs 33.79 ± 18.91 hr, p=.048). These differences remained significant after adjustment for patient characteristics (age, sex, hemodialysis duration, ferritin, PTH and ACEI use). No significant differences between groups were found in maximal Epo concentration, time to maximum Epo concentration, area under the curve from time of dosing extrapolated to infinity, clearance, mean residence time of Epo between groups both before and after adjustment.CONCLUSIONPharmacokinetic analysis of beta-erythropoietin detected a significantly longer elimination half-life in BEN than in non BEN patients. This finding needs to be confirmed in a well-controlled study with a larger sample size.

100 Deals associated with Epoetin beta biosimilar(Cinnagen)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia	India	CinnaGen Co.	01 Jan 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anemia in chronic kidney disease	Phase 1	Iran	CinnaGen Co.	22 Jun 2016
Kidney Failure, Chronic	Phase 1	Iran	CinnaGen Co.	22 Jun 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03408639 (CTgov)	Phase 3	Kidney Failure, Chronic \| Anemia in chronic kidney disease	156	Nephrovit+Vitamin B12 Injection+CinnaPoietin® (CinnaPoietin®)	ydprzjcetn(vpfxukrefx) = ixqwfspdas osbslqwmyf (lecugtkojm, finehpyjmk - dfaizdaqhm) View more	-	06 Nov 2019
NCT03408639 (CTgov)	Phase 3	Kidney Failure, Chronic \| Anemia in chronic kidney disease	156	Nephrovit+Vitamin B12 Injection+Eprex® (Eprex®)	ydprzjcetn(vpfxukrefx) = wspnzwpbse osbslqwmyf (lecugtkojm, xsbwxndytm - zwelledqbk) View more	-	06 Nov 2019
Pananemia 2008 (ASCO2009)	Not Applicable	Neoplasms	591	Erythropoietin beta	(ltsdrseadj) = xnsbjwomaq ramwadhubg (cxnxwaekfr )	-	20 May 2009

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Biosimilar

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