Grafeel (filgrastim biosimilar) / Dr. Reddy’s - LARVOL DELTA

Changes in US payer biosimilar coverage policies of granulocyte colony-stimulating factor products (AMCP 2024) - "For filgrastim biosimilars, 84% of payers preferred Zarxio, whereas Neupogen, Nivestym, and Releuko were most commonly nonpreferred...For pegfilgrastim biosimilars, 62% of payers preferred Ziextenzo, 60% preferred Neulasta, and 55% preferred Fulphila, whereas Nyvepria, Fylnetra, and Stimufend were most commonly nonpreferred. Prefer- ence for Udenyca was split, with 45% of payers preferring this agent and 45% of payers listing it as nonpreferred... Payer policies for granulocyte colony stimu- lating factor biosimilars indicated that Neulasta has retained much of its preferred status, whereas Neupogen is often nonpreferred. In both cases, average time to policy addition was about 4 months after FDA approval. Further, pegfil- grastim policies had more updates to the preferred product status than filgrastim policies, possibly because of more pegfilgrastim biosimilars being approved and marketed."

Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization. (PubMed, South Asian J Cancer) - "The patient who received generic filgrastim had more febrile episodes during the course of transplantation ( p = 0.020). Conclusion Generic filgrastim was found to be comparable to original filgrastim for peripheral blood stem cell mobilization in normal healthy donors for allogeneic HSCT and patients for autologous HSCT."

Journal • Bone Marrow Transplantation • Transplantation • CD34 • CSF3

Comparison of Long-Acting G-CSF (PD-Lasta) with Short-Acting G-CSF (PD-Grastim) in Neutrophil Recovery Following Consolidation Chemotherapy with High-Dose Cytarabine in Acute Myeloid Leukemia: A Randomized Clinical Trial. (PubMed, Int J Hematol Oncol Stem Cell Res) - "Materials and Patients (n = 51) received one or two courses of Cytarabine and Daunorubicin as an induction...Incidence of adverse effects was similar in both short-acting G-CSF (PD-Grastim) and long-acting G-CSF (PD-Lasta) groups. Overall, data show that Iranian long-acting G-CSF (PD-Lasta) was not significantly different with Iranian short-acting G-CSF (PD-Grastim)."

Clinical • Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • CSF3

A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM) (clinicaltrials.gov) - P2; N=160; Not yet recruiting; Sponsor: Array BioPharma

New P2 trial • Biosimilar • Hematological Malignancies • Multiple Myeloma • Oncology

Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov) - P=N/A; N=21; Active, not recruiting; Sponsor: National Cancer Institute (NCI); N=182 -> 21

Enrollment change • Biosimilar • Non Small Cell Lung Cancer • Oncology

Assessing analytical comparability of biosimilars: GCSF as a case study (ACS-Sp 2017) - "In the present work, we use such an analytical platform for assessing comparability of five approved Granulocyte Colony Stimulating Factor (GCSF) biosimilars (Emgrast, Lupifil, Colstim, Neukine and Grafeel) to the innovator product, Neupogen®. For the most part, the biosimilar drugs were found to be comparable to the innovator drug anomaly that was identified was that three of the biosimilars had a typical variant which was reported as an oxidized species in the literature. But, upon further investigation using RPC-FLD and ESI-MS we found that this is likely a conformational variant of the biotherapeutic been studied."

Biosimilar

Assessing analytical comparability of biosimilars: GCSF as a case study. (PubMed) - J Chromatogr B Analyt Technol Biomed Life Sci - "For the most part, the biosimilar drugs were found to be comparable to the innovator drug anomaly that was identified was that three of the biosimilars had a typical variant which was reported as an oxidized species in the literature. But, upon further investigation using RPC-FLD and ESI-MS we found that this is likely a conformational variant of the biotherapeutic been studied."

Journal • Biosimilar