Authors of a post-marketing study of the epoetin alfa biosimilar Retacrit say that the biosimilar is effective and well tolerated in treating chemotherapy-induced anaemia (CIA) [1].
Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.
Hospira’s biosimilar Retacrit (epoetin zeta) was approved in the European Union in December 2007 [2]. The US-based company also submitted an application to the US Food and Drug Administration (FDA) for approval of its epoetin alfa biosimilar in December 2014 [3].
The SYNERGY study aimed to assess the effect of Retacrit on chemotherapy-induced anaemia (CIA) in current practice. The observational, longitudinal, prospective, multicentre study was carried out in France between June 2012 and December 2014 from a representative, random sample of oncologists and haematologists.
The primary objective for the study was response to epoetin alfa biosimilar [achieving target haemoglobin (Hb) level with increase of ≥ 1 g/dL versus baseline or increase of ≥ 2 g/dL in the absence of a transfusion in the 3 previous weeks]. Secondary objectives included patient characteristics and experiences, as well as possible iron deficiency and the impact of iron supplementation.
The results were presented at the ESMO Asia Congress, which was held on 18–21 December 2015 in Singapore.
Oncologists and haematologists (n = 195) enrolled 2,167 patients aged ≥ 18 years with CIA, with solid tumours, lymphoma or myeloma, eligible for treatment with epoetin alfa biosimilar. Retacrit was administered subcutaneously (99.2% of patients) in a single weekly dose of 20,000–40,000 IU for a median duration of 11.0 weeks.
At follow-up (12–16 weeks), 71.9% of patients had a maximum Hb level above 11 g/dL. The mean change ±SD in Hb level was 2.25 ± 1.39 g/dL at its maximum and 1.67 ± 1.55 g/dL at the final visit. The overall response rate to Retacrit was 70.4%; 68.6% for solid tumours, 74.4% for lymphomas and 81.3% for myelomas. Hb levels increased by ≥ 2 g/dL in 57.3% and by 1–2 g/dL in 26.4% of patients. Treatment-related adverse events occurred in 3.4% of patients, mainly thromboembolic events (2.0%). The rate of blood transfusions was 16.3%.
The authors concluded that ‘these results provide real-life evidence that epoetin alfa biosimilar was effective and well tolerated in treating CIA’.
Conflict of interest
Some of the authors of the abstract [1] are employees of, or have received grant and/or research support from, Hospira. For full details of the authors' conflicts of interest, see the research paper [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 as preliminary until published in a peer-reviewed journal.
Related article
Biosimilars in the treatment of chemotherapy-induced anaemia
References
1. Scotté F, Laribi K, Gisselbrecht C, et al. Real-life efficacy of an epoetin alfa biosimilar in chemotherapy-induced anemia. Supportive and palliative care 373PD. ESMO Asia Congress, Singapore, 18-21 December 2015.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Hospira submits application to FDA for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from: www.gabionline.net/Biosimilars/News/Hospira-submits-application-to-FDA-for-epoetin-alfa-biosimilar
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