Study into switching from Aranesp to biosimilar epoetin alfa

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Study into switching from Aranesp to biosimilar epoetin alfa

Biosimilares/Novedades | Posted 07/11/2014 0 Post your comment

Biologicals major Amgen has started recruiting patients for a clinical trial to study the effect of switching patients from the originator biological Aranesp (darbepoetin alfa) to biosimilar epoetin alfa, in other words, from a long-acting to a short-acting epoetin.

The study is being carried out to gain an insight into the clinical outcomes of haemodialysis patients switching from Aranesp to a European Medicines Agency/Therapeutic Goods Administration (EMA/TGA) – approved epoetin alfa biosimilar.

The trial will evaluate various data, including haemoglobin concentrations, dose ratios, iron use and TSAT, ferritin and albumin values, as well as evaluating any cases of pure red cell aplasia (PRCA).

The trial is a retrospective, observational study. Amgen plans to evaluate 320 stable haemodialysis patients treated at dialysis clinics in Europe and Australia after September 2008 who have received treatment with Aranesp for at least 26 weeks prior to being converted to an EMA/TGA-approved epoetin alfa biosimilar. The trial will be carried out across different sites in Bulgaria, Greece, Italy, Poland, and Spain in patients aged 18 years and above. The trial is to be completed by March 2015.

The patents on Amgen’s blockbuster anaemia treatment Aranesp are set to expire in Europe in July 2016 and in the US in May 2024 [1]. Three epoetin alfa biosimilars, Medice Arzneimittel Pütter’s Abseamed, Sandoz’s Binocrit and Hexal’s epoetin alfa Hexal, have been on the market in Europe since they were approved by EMA in August 2007. Two epoetin zeta biosimilars, Hospira’s Retacrit and Stada’s Silapo, also received European approval in December 2007 [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 7]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 7] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: ClinicalTrials.gov