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Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N - Ann. Oncol. (2015)

Bottom Line: This study demonstrates that biosimilar and the reference filgrastim are similar with no clinically meaningful differences regarding efficacy and safety in prevention of severe neutropenia.Biosimilar filgrastim could represent an important alternative to the reference product, potentially benefiting public health by increasing access to filgrastim treatment.NCT01519700.

View Article: PubMed Central - PubMed

Affiliation: Duke University, DUMC, Durham, USA kimberly.blackwell@duke.edu.

No MeSH data available.


Related in: MedlinePlus

Duration of severe neutropenia with biosimilar and reference filgrastim during cycle 1 in the (A) per-protocol and (B) full analysis set populations.
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MDV281F1: Duration of severe neutropenia with biosimilar and reference filgrastim during cycle 1 in the (A) per-protocol and (B) full analysis set populations.

Mentions: Mean DSN for the PP set was 1.17 ± 1.11 days in the biosimilar (N = 101) and 1.20 ± 1.02 days in the reference arm (N = 103). Mean treatment difference was 0.04 days with lower limit of the 97.5% CI of −0.26 days. For the FAS set, DSN was 1.18 ± 1.12 days in the biosimilar (N = 107) and 1.20 ± 1.02 days in the reference arm (N = 107), with a mean treatment difference of 0.02 days and a lower limit of the 97.5% CI of −0.27 days. Biosimilar was noninferior to the reference, because the lower bound of the 97.5% CI was entirely above the predefined noninferiority margin of −1 day (Figure 1).Figure 1.


Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N - Ann. Oncol. (2015)

Duration of severe neutropenia with biosimilar and reference filgrastim during cycle 1 in the (A) per-protocol and (B) full analysis set populations.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4551159&req=5

MDV281F1: Duration of severe neutropenia with biosimilar and reference filgrastim during cycle 1 in the (A) per-protocol and (B) full analysis set populations.
Mentions: Mean DSN for the PP set was 1.17 ± 1.11 days in the biosimilar (N = 101) and 1.20 ± 1.02 days in the reference arm (N = 103). Mean treatment difference was 0.04 days with lower limit of the 97.5% CI of −0.26 days. For the FAS set, DSN was 1.18 ± 1.12 days in the biosimilar (N = 107) and 1.20 ± 1.02 days in the reference arm (N = 107), with a mean treatment difference of 0.02 days and a lower limit of the 97.5% CI of −0.27 days. Biosimilar was noninferior to the reference, because the lower bound of the 97.5% CI was entirely above the predefined noninferiority margin of −1 day (Figure 1).Figure 1.

Bottom Line: This study demonstrates that biosimilar and the reference filgrastim are similar with no clinically meaningful differences regarding efficacy and safety in prevention of severe neutropenia.Biosimilar filgrastim could represent an important alternative to the reference product, potentially benefiting public health by increasing access to filgrastim treatment.NCT01519700.

View Article: PubMed Central - PubMed

Affiliation: Duke University, DUMC, Durham, USA kimberly.blackwell@duke.edu.

No MeSH data available.


Related in: MedlinePlus