Real-life data supports efficacy and safety of biosimilar filgrastim

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Real-life data supports efficacy and safety of biosimilar filgrastim

Biosimilares/Investigación | Posted 18/08/2017 0 Post your comment

Biosimilars of filgrastim are widely used in the prophylaxis of chemotherapy‐induced (CIN) and febrile neutropenia (FN). However, there are limited observational data on the use of granulocyte colony-stimulating factor (G‐CSF) in non‐Hodgkin’s lymphoma (NHL) and its aggressive subtypes including diffuse large B‐cell lymphoma (DLBCL).

In order to address the lack of data in DLBCL patients the MONITOR‐GCSF study was initiated. This is a pan‐European, multicentre, prospective, observational study that aims to describe treatment patterns and clinical outcomes in patients receiving biosimilar filgrastim (Zarzio/Zarxio/EP2006 Hexal) in the prophylaxis of CIN/FN.

Hexal’s Filgrastim Hexal (EP2006) and Sandoz’s Zarzio were approved in the European Union back in February 2009 [2]. More recently, Zarxio was approved in the US, as the US Food and Drug Administration’s first ever biosimilar approval, in March 2015 [3].

The data from this study [1] was presented at the 14th International Conference on Malignant Lymphoma, which was held at the Palazzo dei Congressi, Lugano (Switzerland) on the 14−17 June 2017.

Data from 245 evaluable patients with stage 3 or 4 DLBCL receiving up to 6 chemotherapy cycles was included in the analysis. CIN (any grade) occurred in 16.7% (n = 41) of patients in Cycle 1 and in 35.5% (n = 87) of patients in all cycles. FN occurred in 2.4% (n = 6) of patients in Cycle 1 and in 9.8% (n = 24) of patients in all cycles. Grade 3−4 FN occurred in 2% of patients (n = 5) in Cycle 1 and in 9.4% of patients (n = 23) in all cycles. The most frequent adverse event was bone pain, reported in 2.9% of patients (n = 7), followed by arthralgia (0.8%; n = 2) and back pain (0.8%; n = 2).

The authors concluded that ‘the efficacy and safety of biosimilar filgrastim in real‐life practice in patients with DLBCL are similar to the known efficacy and safety profile of reference filgrastim’. They added that ‘this supports the use of biosimilar filgrastim in real‐world use and extends the efficacy and safety from its clinical development program’.

Conflict of interest
The authors of the abstract [1] did not provide any conflict of interest statement. However, several authors are employees of Hexal.

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.

References
1. Gascon P, Krendyukov A, Höbel N, Aapro M. Treatment patterns and outcomes in the DLBCL cohort of a study (MONITOR-GCSF) assessing biosimilar filgrastim for prophylaxis of chemotherapy-induced/febrile neutropenia. Hematological Oncology. 2017;35(S2):351.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 18]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar

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