Real-world safety data for epoetin alfa biosimilar

Biosimilars/Research | Posted 01/07/2016 post-comment0 Post your comment

A 2-year post-marketing study of the epoetin alfa biosimilar Binocrit has found the biosimilar to be safe in daily clinical practice, according to the authors [1].

Health and Safety V15C26

The Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5 (MONITOR-CKD5) study was completed in November 2014. The study followed haemodialysis patients in real-world practice over a period of 24 months and reported data on adverse drug reactions (ADRs) and (serious) adverse events (S/AEs).
 
Safety data from the study was presented at the 53rd European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress held in Vienna, Austria on 21–24 May 2016.

The observational, pharmaco-epidemiological study included 2,086 patients with Stage 5 chronic kidney disease requiring haemodialysis.

In the evaluable sample (n = 2,023) 291 (14.4%) patients experienced a thrombo-embolic event (TEE), mainly shunt thrombosis (164/8.1%), myocardial ischaemia/infarction (68/3.4%) and cerebrovascular accident (34/1.7%) (all other TEEs ≤ 1.0%). Other clinical events (≥ 1.0%) observed were infection requiring treatment (681/33.7%), surgery excluding transplant (315/15.6%), bleeding with significant blood loss (172/8.5%), and red blood cell transfusion (RBCTx) for reasons other than renal anaemia (107/5.3%). In total, 345 (17.1%) patients were hospitalized during the study, mainly once (193/9.5%) or twice (59/2.9%), and mainly for surgical/medical procedures (135/6.7%), infections and infestations (83/4.1%) or injury, poisoning and procedural complications (77/3.8%).

In the safety sample (n = 2,086), 140 patients (6.7%) were reported to have experienced an AE or SAE, including 16 (0.8%) stated to be related. Of these 140 patients, 108 (5.2%) were reported to have experienced an SAE, including 11 (0.5%) stated to be related.

From this data the authors concluded that ‘the real-world safety profile of Binocrit, a biosimilar epoetin alfa, is consistent with the profile of originator epoetin alfa’.

Binocrit was approved in the European Union (EU) in August 2007 [2]. Sandoz also has two other biosimilars approved in the EU, Omnitrope (somatropin) and Zarzio (filgrastim) [2]. The company also gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 [3] – the first biosimilar to be approved in the US. It has also submitted applications for approval of its etanercept (GP2015) and pegfilgrastim (LA-EP2006) biosimilars to both the US Food and Drug Administration [4, 5] and the European Medicines Agency [6, 7].

Conflict of interest
The author of the abstract [1] did not provide any conflict of interest statement. However, some of the authors work for Sandoz as shown in the authors’ affiliations. For full details, see the authors’ affiliations in the abstract [1].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

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References
1. Goldsmith D, et al. SP558: 24-month safety outcomes of biosimilar epoetin alfa in the European MONITOR-CKD5 pharmacoepidemiological study of anaemia in haemodialysis. 53rd ERA-EDTA Congress; 21-24 May 2016; Vienna, Austria.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Zarxio first biosimilar to be launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jul 1]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar

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