Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

Below is a roundup of several recently published comparative studies between biosimilars and reference biologics.

In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically meaningful differences in the safety profile of Cinfa Biotech’s B12019 biosimilar to Neulasta® (pegfilgrastim) compared with pegfilgrastim.  In the multiple-dose, randomized, double-blind, 3-period, 2-sequence crossover study, which investigated the immunogenicity and pharmacodynamics of B12019 compared to pegfilgrastim, patients were given a reduced dose of 3 mg, compared with the clinical dose of 6 mg.  According to the study authors, this dose is considered to be more sensitive to potential differences between B12019 and pegfilgrastim than the 6 mg clinical dose.  We had previously reported on Cinfa’s biosimilar to pegfilgrastim here.

A study published in the Journal of the American Medical Association concluded that Mylan and Biocon’s MYL-1401O biosimilar to Herceptin® (trastuzumab) was comparable to trastuzumab for women with ERBB2-positive metastatic breast cancer.  The study compared overall response rate (ORR) safety of MYL-1401O plus a taxane or trastuzumab plus a taxane in patients without prior treatment.  The authors concluded that “Among women with ERBB2-positive metastatic breast cancer receiving taxanes, the use of a proposed trastuzumab biosimilar compared with trastuzumab resulted in an equivalent overall response rate at 24 weeks.”  We had previously reported on Mylan and Biocon’s biosimilar to trastuzumab here.

The MONITOR-CKD5 study published in Clinical Nephrology concluded that patients with renal anemia undergoing hemodialysis who were treated for up to 24 months with Sandoz’s intravenous biosimilar epoetin alfa HX575 (Binocrit) showed hemoglobin (Hb) outcomes equivalent to reference epoetin alfa.  The study, which was carried out in 114 centers in 10 European countries, enrolled 2086 patients, of which 1000 completed all follow-up visits and comprised the evaluable enrollment sample.  The authors concluded that the study “confirmed the real-world effectiveness and safety profile of IV biosimilar HX575.  [Hemodialysis] patients treated for up to 24 months showed stable dosing patterns and Hb outcomes. The safety profile of HX575 is likewise comparable to reference epoetin.”

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