The study randomized and dosed 589 patients with breast cancer with either the biosimilar, the EU-licenced reference pegfilgrastim, or the US-licensed reference pegfilgrastim.
Multiple drug makers are undertaking development of biosimilar pegfilgrastim, a long-acting granulocyte-colony stimulating factor therapy that can reduce the incidence of febrile neutropenia (FN). Among those drug makers is Apotex, which has developed a biosimilar that is approved in Canada under the name Lapelga (in the United States, Apotex was long embroiled in a legal case with Amgen, maker of the reference pegfilgrastim, Neulasta).
While a timeline for US regulatory consideration and potential approval of the biosimilar is not clear, a recently published paper reports on findings from a 3-way, randomized equivalence study for the biosimilar versus both US- and EU-licensed reference pegfilgrastim.
Read more about biosimilar pegfilgrastim.
The study randomized and dosed 589 patients with breast cancer—at 56 center in 11 countries—who were scheduled to receive docetaxel, doxorubicin, and cyclophosphamide chemotherapy. A total of 294 patients received the biosimilar, 148 received the US reference, and 147 received the EU reference. The study’s primary endpoint, chosen for its sensitivity, was the assessment of the duration of severe neutropenia—defined as an absolute neutrophil count below 0.5 × 109/L—in the first cycle of chemotherapy.
For the as randomized population, the 95% confidence interval (CI) of the difference in mean duration of severe neutropenia in cycle 1 between the biosimilar and US reference was outside of the equivalence margin (±0.5 days) by 0.01 days, but the authors write that this difference is not considered clinically significant, and that an equivalence margin of  ±1 day is typical in such studies. The 95% CI of the difference in mean duration of severe neutropenia between the biosimilar and the EU reference, however, was contained within the pre-defined margin.
The number of adverse events (AEs) in the 3 treatment arms was similar. In total, 295 AEs were reported in the biosimilar group (89.7%), 128 were reported in the US reference group (94.8%), and 116 were reported in the EU reference group (92.8%). Most AEs were mild to moderate in severity, and the most commonly reported AEs were neutropenia and nausea. No unexpected safety events were reported in the biosimilar group, and no clinically meaningful effects associated with anti-drug antibodies were observed.
The authors concluded that these results demonstrate the similarity of the Apotex pegfilgrastim product to both the US- and EU-licensed reference in terms of both clinical efficacy and safety.
Reference
Desai K, Misra P, Kher S, Shah N. Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy. Exp Hematol Oncol. 2018;7:22. doi: 10.1186/s40164-018-0114-9.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Annual STADA Report Shows Record Profit Growth for 2023
March 25th 2024Germany-based biosimilar manufacturer STADA Arzneimittel reports strong financial performance in 2023 with double digit sales growth and billions in profits. The CEO credits the company’s success on their strong company culture and focus for innovation.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.