Delving into the Latest Updates on Epoetin alfa(Sandoz International GmbH) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Abseamed, Aczicrit, Binocrit

+ [11]

Target

EPO receptor

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists)

Therapeutic Areas

Hemic and Lymphatic DiseasesUrogenital Diseases

Active Indication

AnemiaAnemia of renal diseasechronic renal failure anemia

Inactive Indication

Neoplasms

Originator Organization

Sandoz International GmbH

Active Organization

MEDICE Arzneimittel Pütter GmbH & Co. KGSandoz GmbH

Hexal AG

+ [1]

Inactive Organization

Sandoz AGSandoz Research Institute

Drug Highest PhaseApproved

First Approval Date

EU (27 Aug 2007),

Anemia of renal diseaseAnemiachronic renal failure anemia

Regulation-

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Gene Sequence

Sequence Code 9003

The sequence is quoted from: *****

The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.

Start Date28 Feb 2013

Sponsor / Collaborator

Azidus Brasil

NCT01685333 / CompletedPhase 1

Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Single Dose, Intravenous Administration in Healthy Subjects: a Randomized Crossover Study.

The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a single-dose intravenous administration of 100 IU/kg in healthy subjects.

Start Date28 Feb 2013

Sponsor / Collaborator

Azidus Brasil

NCT01693029 / CompletedPhase 3

Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Start Date01 Sep 2012

Sponsor / Collaborator

Sandoz AG

100 Clinical Results associated with Epoetin alfa(Sandoz International GmbH)

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100 Translational Medicine associated with Epoetin alfa(Sandoz International GmbH)

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100 Patents (Medical) associated with Epoetin alfa(Sandoz International GmbH)

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43

Literatures (Medical) associated with Epoetin alfa(Sandoz International GmbH)

01 Dec 2023·Drug safety

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

Review

Author: Cohen, Hillel P ; Kottke, Andrea ; Kalsekar, Sameer ; Anjaneya, Pradeep ; Sagi, Sreedhar

BACKGROUND:

Biosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still lingering concerns related to the long-term safety of biosimilars. Therefore, we reviewed the post-approval pharmacovigilance data for eight marketed biosimilars from one Marketing Authorization Holder (MAH) to summarize their safety experience in a real-world setting for up to 18 years since their first biosimilar launch.

METHODS:

Post-approval cumulative patient exposure and safety experience for eight Sandoz biosimilars [adalimumab (Hyrimoz^®), epoetin alfa (Binocrit^®), etanercept (Erelzi^®), filgrastim (Zarzio^®), infliximab (Zessly^®), pegfilgrastim (Ziextenzo^®), rituximab (Rixathon^®), and somatropin (Omnitrope^®)] was summarized based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding health authority-authored PSUR assessment reports, where available, as of 31 January 2023. Exposure to all biosimilars was calculated in patient treatment days (PTD) except for rituximab, which was expressed in number of patient doses (PD).

RESULTS:

The combined post-approval cumulative exposure to seven out of the eight marketed Sandoz biosimilars was more than 1.3 billion PTD and for rituximab more than 1.8 million PD. Overall, a critical analysis of the cumulative safety data of all eight Sandoz biosimilar PSURs concluded that the overall benefit-risk profile of each remains favorable and is consistent with the respective reference biologics.

CONCLUSIONS:

This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.

01 Jan 2023·Critical reviews in oncology/hematology

Epoetin alfa biosimilar (HX575): A review of 15 years’ post-approval clinical experience

Review

Author: Zabransky, Markus ; Gascón, Pere ; Goldsmith, David ; Esmael, Altaher ; Dellanna, Frank ; Aapro, Matti

Biosimilars offer the potential to expand patient access and reduce healthcare costs. Therefore, it is of importance that clinicians and patients are reassured about their efficacy and safety in practice. In 2007, Binocrit® (HX575; Sandoz GmbH, Kundl, Austria) was the first epoetin alfa biosimilar approved for use in chemotherapy induced anaemia (CIA), chronic renal failure (CRF), and more recently myelodysplastic (MDS) anaemia. Since its approval, there has been a plethora of data demonstrating the well-tolerated safety profile of HX575. This review will outline the safety results collected from key studies that have added to the extensive HX575 (Binocrit® unless otherwise stated) clinical experience. With a focus on all approved indications, we will review the safety data collected across a range of study types, to further consolidate the reassurance for the use of HX575 in these indications.

01 Jan 2023·Cancer treatment and research communications

Fatigue visual analogue scale score correlates with quality of life in cancer patients receiving epoetin alfa (Sandoz) for chemotherapy-induced anaemia: The CIROCO study

Article

Author: Baize, Nathalie ; Nabirotchkina, Ekatérina ; Stefani, Laetitia ; Choquet, Sylvain ; Hjiej, Salim ; Laribi, Kamel ; Anota, Amélie ; Desramé, Jerome ; Zelek, Laurent

PURPOSE:

Available tools to measure fatigue and health-related quality of life (HRQoL) in cancer patients are often difficult to use in clinical practice. The fatigue visual analogue scale (VAS) provides a simple method to assess fatigue. This study evaluated the correlation between HRQoL and fatigue perceived by cancer patients undergoing chemotherapy.

METHODS:

This was a non-interventional prospective study of adult cancer patients in France presenting with chemotherapy-induced anaemia (CIA) treated with epoetin alfa (Sandoz). Data were collected using an electronic case report form at study inclusion (T0), after 2-3 chemotherapy cycles (T1) and after 4-6 cycles (T2).

RESULTS:

The study included 982 patients from September 2015 to October 2017. Overall, there was a negative correlation between fatigue VAS and HRQoL. The overall haemoglobin (Hb) change between T0 and T2 was +17.8 % (± 18.1 %). Fatigue assessed by both patients and physicians showed a clinically significant improvement during the study. Global HRQoL also increased.

CONCLUSION:

Treatment of CIA with epoetin alfa (Sandoz) improved Hb levels, fatigue, and HRQoL, with a correlation observed between fatigue VAS score and HRQoL. Fatigue VAS could act as a simple alternative to more complex methods to measure HRQoL; however, further analyses are required to confirm this association.

100 Deals associated with Epoetin alfa(Sandoz International GmbH)

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External Link

KEGG	Wiki	ATC	Drug Bank
D03231	-	B03XA01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia	EU	Hexal AG	27 Aug 2007
Anemia	EU	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia	IS	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia	IS	Hexal AG	27 Aug 2007
Anemia	LI	Hexal AG	27 Aug 2007
Anemia	LI	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia	NO	Hexal AG	27 Aug 2007
Anemia	NO	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	EU	Hexal AG	27 Aug 2007
Anemia of renal disease	EU	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	IS	Hexal AG	27 Aug 2007
Anemia of renal disease	IS	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	LI	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	LI	Hexal AG	27 Aug 2007
Anemia of renal disease	NO	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	NO	Hexal AG	27 Aug 2007
chronic renal failure anemia	EU	Hexal AG	27 Aug 2007
chronic renal failure anemia	EU	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
chronic renal failure anemia	IS	Hexal AG	27 Aug 2007
chronic renal failure anemia	IS	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	Phase 3	DE	Sandoz AG	01 Apr 2012
Chronic Kidney Diseases	Phase 3	IT	Sandoz AG	01 Apr 2012
Chronic Kidney Diseases	Phase 3	PL	Sandoz AG	01 Apr 2012
Chronic Kidney Diseases	Phase 3	RO	Sandoz AG	01 Apr 2012
Chronic Kidney Diseases	Phase 3	RU	Sandoz AG	01 Apr 2012
Chronic Kidney Diseases	Phase 3	TR	Sandoz AG	01 Apr 2012
Chronic Kidney Diseases	Phase 3	UA	Sandoz AG	01 Apr 2012
Neoplasms	Phase 3	DE	Hexal AG	01 Nov 2004
Neoplasms	Phase 3	DE	Sandoz Research Institute	01 Nov 2004
Neoplasms	Phase 3	RO	Hexal AG	01 Nov 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01576341 (SENSE, Pubmed \| Clin Nephrol) Manual	Phase 3	Anemia \| Chronic Kidney Diseases	416	HX575 Epoetin Alfa	evkloexnjm(pmkxwdlqam) = xfcjstmcwn wqojzyofof (kuojrgneti )	Positive	01 Oct 2017
NCT00666835 (CTgov)	Phase 3	Anemia	478	HX575 epoetin alfa Hexal AG (HX575 Epoetin Alfa Hexal AG)	ndtdzdhogk(lvaledipwf) = mbwzazoumr fllcnnyjib (kmytrfbtat, phlkjhzhci - filigujhun) View more	-	02 Aug 2017
				ERYPO®, Janssen-Cilag (ERYPO®, Janssen-Cilag)	ndtdzdhogk(lvaledipwf) = dipltlrqeh fllcnnyjib (kmytrfbtat, ntxxdaiekl - envnenpjxi) View more
NCT01576341 (SENSE, CTgov)	Phase 3	Anemia \| Chronic Kidney Diseases	417	HX575 (HX575)	youjsffhlb(vbedyaoqgj) = zmzfcxlemc fftfxmpzqo (jvtcwwzxvm, nazmyrfqmu - sprnlwnzgv) View more	-	19 Jun 2017
				ESA+HX575 (HX575 - ESA Naive)	raethqrtqy(ezpsusrrrx) = axqfywpfqa vdcuvtylux (vstmcmdkky, ephyiohrrf - qpbmtkokbk) View more
NCT01693029 (ACCESS, CTgov)	Phase 3	Anemia \| Chronic Kidney Diseases	435	HX575 epoetin alfa (HX575 Epoetin Alfa)	bthavnkgfv(wtmjmctgky) = vvbgdtmcxm tzaytmcocr (slqnilwwdz, egdghkqxxt - isdkmujoqf) View more	-	12 May 2017
				US-licensed epoetin alfa (US-licensed Epoetin Alfa)	bthavnkgfv(wtmjmctgky) = aovbxfesxr tzaytmcocr (slqnilwwdz, kxubghrtqp - zifjzrbjrt) View more
NCT01693029 (Pubmed \| Am J Nephrol) Manual	Phase 3	Kidney Failure, Chronic	-	Epoetin Alfa+HX575	etoucxkree(xbcpxermmu): difference = -0.093 (90% CI, -0.23 to 0.04)	Similar	01 Jan 2017
				Epoetin Alfa
ASN2014	Not Applicable	Hb \| CRP \| PTH ... View more	1,545	HX575 (Biosimilar Epoetin Alpha, Binocrit)	bccbpiksxu(rbzklgsaox) = qrnvfqyeux yqwikhkaxq (tzsmsfolck, -5.6 to -0.7)	Negative	11 Nov 2014
				Darbepoetin Alpha (Aranesp)	bccbpiksxu(rbzklgsaox) = hvbwbxzerd yqwikhkaxq (tzsmsfolck, 1.6 - 5.5)
MONITOR-CKD5 (ASN2014)	Not Applicable	Anemia in chronic kidney disease	2,087	HX575	asjzegfnva(tuciczvqkp) = gfmtlarssk nwwkmfvdyh (bgwvvajqqb ) View more	Positive	11 Nov 2014
BOS (ASN2010)	Not Applicable	Maintenance	332	ESA treatment by Binocrit	ulvbgrtzol(vpimrecmis) = bifdvzrlxj nchmftmtal (ngvcxgyglu, 56) View more	Positive	16 Nov 2010
not available (ASN2010)	Not Applicable	Chronic Kidney Diseases	1,695	HX575 (Epoetin alfa)	hoiogrctwv(xzxexiaumh) = No subject developed anti-epoetin antibodies during the study rmynnafhtl (ihenhxamee ) View more	Positive	16 Nov 2010