SciLocyte (filgrastim biosimilar) / Bioton, Yifan Pharma, Intas, Apotex, Stada - LARVOL DELTA

THE REAL-WORLD EXPERIENCE OF THE FILGRASTIM BIOSIMILAR (GRASTOFIL®) TO THE REFERENCE BIOLOGIC (NEUPOGEN®):A CANADIAN SINGLE-CENTRE RETROSPECTIVE STUDY (MASCC-ISOO 2022) - "Dose reductions and dose delays for both cohorts also suggested non-inferiority. Conclusions This study suggests a real-world clinical comparability and non-inferiority of the biosimilar and supports its continued adoption."

Real-world evidence • Retrospective data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology • Solid Tumor

The Real-World Experience of the Biosimilar (Grastofil) to the Reference Biologic (Neupogen) in Breast Cancer and Lymphoma: A Canadian Single-Centre Retrospective Study. (PubMed, Curr Oncol) - "This cohort was further split into breast cancer (n = 275) and non-Hodgkin's lymphoma (n = 31) cohorts. After adjusting for chemotherapy cycles, the biosimilar filgrastim was non-inferior to the reference biologic based on FN incidence in addition to related outcomes including DR and DD."

Journal • Real-world evidence • Retrospective data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Efficacy and safety of filgrastim biosimilar Accofil® - real-world data - (DGHO 2021) - "Supportive therapy with Accofil® in patients receiving cytotoxic chemotherapy is effective and safe in real world conditions. Accofil® led to a statistically significant increase of neutrophil counts (p <0.001) and consequently to a reduced frequency, severity and duration of neutropenia and to a reduced risk of FN. In all relevant aspects Accofil ® compared well to G-CSF “original” and to other G-CSF biosimilars."

Clinical • Real-world evidence • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology

One Canadian payer's experience with biosimilars (Center for Biosimilars) - "For the biosimilars that have entered the Canadian market, discounts have ranged from 17% (for Grastofil, a biosimilar filgrastim referencing Neupogen) to 50% (for Renflexis, a biosimilar infliximab referencing Remicade). 'Prices are all over the place,' but the big story in Canada has been Renflexis’ discount on Canadian drug with the highest annual spending, he said."

Pricing • Ankylosing Spondylitis • Immunology • Inflammatory Bowel Disease • Neutropenia • Psoriasis • Rheumatoid Arthritis

District court denies Apotex’s motion to dismiss Amgen’s complaint in second lawsuit (Big Molecule Watch) - "...the district court in Amgen v. Apotex (No. 18-61828) (S.D. Fla.) denied Apotex’s motion to dismiss Amgen’s complaint in a follow-on suit concerning Apotex’s pegfilgrastim and filgrastim biosimilar candidates."

Corporate lawsuit • Neutropenia

Real World Clinical Experience of Biosimilar G-CSF (Grastofil) for Autologous Peripheral Blood Stem Cell Mobilization: Single Center Experience in Canada Following Early Adoption. (PubMed, Curr Oncol) - "Extrapolation of indications for biosimilars is justified. This real-world evidence builds upon registrational studies to confirm that no clinically meaningful differences were detected between originator Neupogen and biosimilar Grastofil in the setting of PBSC mobilization and engraftment post ASCT. Biosimilars are as safe and effective as originator products. Implementation across all approved indications without hesitation maximizes cost savings to the provincial system, allowing for more optimal allocation of health care resources."

Clinical • Journal • Real-world evidence • Hematological Malignancies • Oncology • Transplantation • CD34 • CSF3

COMPARISON OF BIOSIMILAR WITH ORIGINATOR FILGRASTIM FOR THE PRIMARY PROPHYLAXIS OF FEBRILE NEUTROPENIA: EXPERIENCE AT THE SUNNYBROOK ODETTE CANCER CENTRE (SOCC) IN CANADA (MASCC-ISOO 2019) - "The incidence of FN in patients who received PPx with Grastofil® was comparable to patients who received PPx with Neupogen®. Moving forward, Grastofil® and Neupogen® patients will be case-matched for chemotherapy regimen, planned dose intensity, age at treatment, hemoglobin, sex and bone marrow involvement (for lymphoma patients only), in a 1:1 ratio to compare the rates of FN with an equivalence statistical design."

Breast Cancer • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology

Potential and Realized Cost Savings with the Use of the Biosimilar Grastofil Vs Neupogen (ASH 2019) - "The use of biosimilars represents an opportunity for cost savings to be realized in an over-extended health care system. Although there appears to be acceptance for the use of Grastofil® as the overall purchases trended up from 2016 to 2018, there are still significant cost savings that could be realized by greater use of biosimilar drugs."

HEOR • Hematological Disorders • Neutropenia • Oncology

Canadian study shows substantial savings possible with use of biosimilar filgrastim (Center for Biosimilars) - "They found that, during the period studied, the biosimilar accounted for 27% of filgrastim purchases, and a total of $62,061,576 (USD $47,127,078) in spending, while the brand-name filgrastim, Neupogen, accounted for $204,152,590 (USD $155,025,310). Biosimilar use therefore generated $13,443,873 (USD $10,208,739) in savings, but could have generated $36,348,476 (USD $27,601,578) had the biosimilar been used in 100% of cases."

Retrospective data • Neutropenia