Results of an observational study found no difference in Biocad’s non-originator filgrastim (Leucostim) compared to Neupogen in the recovery periods for patients with chemotherapy-induced neutropenia [1].
Russian biologicals manufacturer Biocad launched its non-originator filgrastim (Leucostim) in Turkey in November 2009 [2]. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.
The results of the national observational study were presented at the European Society for Medical Oncology (ESMO) 2014 Congress held in Madrid, Spain, on 26–30 September 2014.
The study enrolled 337 patients receiving chemotherapy and suffering from neutropenia, who had received either non-originator (Leucostim) or originator (Neupogen) filgrastim. Non-originator filgrastim 30 MU (0.3 mg/mL) was administered to 61.9% of patients, originator filgrastim 30 MU to 8.9% and originator filgrastim 48 MU (0.96 mg/mL) to 29.2%.
Recovery in four days was observed in 60.1% of the patients receiving non-originator filgrastim 30 MU, in 56.7% of those that received originator filgrastim 30 MU and in 52.6% of those that received originator filgrastim 48 MU. There was no statistically significant difference in the neutropenia recovery periods for all of the drugs (p > 0.05). There was also no statistically significant difference between non-originator filgrastim 30 MU compared to originator filgrastim 30 MU in the recovery periods (p > 0.05).
The authors therefore concluded that there was no difference between the non-originator and originator filgrastim in patients with chemotherapy-induced neutropenia.
Biocad is actively pursuing non-originator biologicals. The company received approval for its non-originator rituximab drug, AcellBia (BCD-20) from the Russian Ministry of Health in April 2014. The drug is a non-originator biological of Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab) [3].
According to ClinTrials.gov, Biocad is also carrying out phase III clinical trials for two of its other non-originator biological candidates, BCD-021 and BCD-022. The products are non-originator biologicals of Roche’s blockbuster cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab) [4].
Conflict of interest
The authors of the abstract [1] declared that there were no conflicts of interest.
Editor’s comment
It should be noted that this study 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. Sevinc A, Ozkan M, Ozet A, et al. Comparison of the efficacy of filgrastim (Neupogen) and biosimilar filgrastim (Leucostim) in patients with chemotherapy-induced neutropenia: A nationwide observational study. Ann Oncol. 2014;25(4):525. Abstract 1501P.
2. GaBI Online - Generics and Biosimilars Initiative. Timing of the launch of biosimilars in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Biosimilars/Research/Timing-of-the-launch-of-biosimilars-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-Russia
4. GaBI Online - Generics and Biosimilars Initiative. Amgen and Pfizer seek deal with Russian biosimilars firm [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Pharma-News/Amgen-and-Pfizer-seek-deal-with-Russian-biosimilars-firm
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