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Research Finds Biosimilar Filgrastim as Efficient as Its Reference in PBSC Mobilization
A recent study, published in Transfusion, analyzed 3 granulocyte-colony-stimulating factor treatments in an attempt to compare the mobilization efficiency of 2 innovator G-CSF treatments with that of 1 biosimilar treatment.
In patients with multiple myeloma (MM) who are eligible for autologous blood stem cell transplantation, high-dose chemotherapy followed by transplantation is standard first-line therapy. After a patient receives 3 to 4 cycles of induction therapy, 1 cycle of mobilization-specific chemotherapy is typically followed by the administration of a granulocyte-colony-stimulating factor (G-CSF) treatment to facilitate the mobilization of peripheral blood stem cells (PBSCs) prior to collection.
A recent study, published in Transfusion, analyzed 3 G-CSF treatments in an attempt to compare the mobilization efficiency of 2 innovator G-CSF treatments with that of 1 biosimilar treatment.
The retrospective study compared the mobilization efficiency of reference filgrastim (Neupogen), lenograstim (Granocyte), and biosimilar filgrastim (Filgrastim Hexal) in a homogeneous group of 250 patients with MM in first-line treatment. Of this group, 30% (n = 73) received the reference filgrastim, 52% (n = 131) received biosimilar filgrastim, and 18% (n = 45) received lenograstim. Each patient received a subcutaneous dose of 5 to 10 µg per kilogram of body weight beginning at day 5 after chemomobilization until the collection of CD34-positive (CD34+) cells was complete.
The study found that there were no significant differences in mobilization of CD34+ cells or in collection yields among the reference filgrastim group (median: 10 CD34+ cells × 106/kg body weight; range: 2.7 to 40.4), the biosimilar filgrastim group (median: 9.9; range: 0.2 to 26.0) and the lenograsim group (median 10.7; range: 3.1 to 27.9). Overall, 249 of the 250 patients reached the collection goal of 2 × 106 CD34+ cells per kilogram of body weight during a median of 1 (range: 1 to 3) collection session.
The researchers concluded that there were no significant differences in PBSC mobilization or in reaching individual collection targets among innovator treatments and the biosimilar treatment in patients with MM.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Breaking Down Biosimilar Barriers: Payer and PBM Policies
November 13th 2024Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
