Fulphila (pegfilgrastim-jmdb) / Biocon - LARVOL DELTA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 June 2025 (European Medicines Agency) - "On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vivlipeg, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy. The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited."

CHMP • Chemotherapy-Induced Neutropenia • Febrile Neutropenia

Patterns of Medicare Utilization and Spending on Granulocyte Colony-Stimulating Factors: Filgrastim, Pegfilgrastim, and Their Biosimilars (ASH 2024) - "Data for Neupogen and its biosimilars (Zarxio, Nivestym, Granix) and Neulasta and its biosimilars (Fulphila, Udenyca, Ziextenzo and Nyvepria) was extracted. Neulasta maintains the lowest average spending per beneficiary, highlighting its ongoing value proposition despite the increasing role of biosimilars in the treatment landscape. In conclusion, by leveraging the market competition from biosimilars, the healthcare system can achieve a more balanced approach to delivering high-quality care while managing costs effectively."

Medicare • Reimbursement • US reimbursement • Hematological Disorders

Biocon Q2FY25 Revenue at Rs 3,623 Cr, EBITDA at Rs 718 Cr (Biocon Press Release) - "Biocon Biologics has positioned itself as a strategic player among customers, payors, and patients in North America...Its Oncology franchise, comprising Ogivri (Trastuzumab) and Fulphila (Pegfilgrastim), is witnessing robust demand with a marked YoY increase in market share. The market share for Ogivri increased to 18% from 11%, while Fulphila rose to 21% from 15% (YoY)."

Commercial • Breast Cancer • Chemotherapy-Induced Neutropenia • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars (Center for Biosimilars) - "According to a study by Cencora, there is a discrepancy in payer coverage for granulocyte colony-stimulating factor (G-CSF) biosimilars. Although filgrastim biosimilars are frequently preferred over the originator (Neupogen), reference pegfilgrastim (Neulasta) continues to hold a dominant position over its biosimilar counterparts....From the analyzed payers, 38 (76%) had policies for filgrastim and 42 (84%) has policies for pegfilgrastim....For filgrastim biosimilars, 32 (84%) payers preferred Zarxio (filgrastim-sndz), which was the first biosimilar approved in the US. Nivestym (filgrastim-aafi) was the second most preferred filgrastim product, with 14 (37%) payers selecting it as the preferred product....Regarding pegfilgrastim biosimilars, 62% (n = 26) of payers preferred Ziextenzo, 60% (n = 25) preferred Neulasta, 55% (n = 23) preferred Fulphila."

Reimbursement • Oncology

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."

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries (Biocon Press Release) - "Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd...announced the successful completion of the transition of the acquired biosimilars business in ~120 countries across Advanced and Emerging Markets, a year ahead of schedule....All Viatris’ biosimilar brands, including Ogivri® & Hertraz® (bTrastuzumab), Abevmy® (bBevacizumab), Fulphila® (bPegfilgrastim)...and Kirsty® (bAspart), will now be marketed by Biocon Biologics teams, ensuring business continuity for patients, prescribers, partners, and healthcare systems."

M&A • Chemotherapy-Induced Neutropenia • CNS Tumor • Gastrointestinal Cancer • Oncology • Solid Tumor

Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study. (PubMed, J Manag Care Spec Pharm) - "OBJECTIVE: To compare the risk of febrile neutropenia (FN) among users of pegfilgrastim biosimilars (pegfilgrastim-jmdb and pegfilgrastim-cbqv) and the originator product...These results add further to the current evidence on pegfilgrastim biosimilars and support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients. Future studies assessing the tolerability, side effects, and other safety issues of pegfilgrastim biosimilars are needed."

HEOR • Journal • Retrospective data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A population-based analysis of prophylactic G-CSF biosimilar and originator administration over time among patients diagnosed with breast cancer (SABCS 2022) - "Chemotherapy regimens included cyclophosphamide/doxorubicin (n=7,377), carboplatin/docetaxel/trastuzumab/pertuzumab (n=1,862), cyclophosphamide/docetaxel (n=1,383), carboplatin/docetaxel/trastuzumab (n=430), cyclophosphamide/docetaxel/doxorubicin (n=147), and docetaxel/trastuzumab/pertuzumab (n=128)...Eight hundred fifteen (7%) patients received intermediate-risk chemotherapy and G-CSF utilization was, 716 (88%) pegfilgrastim, 27 (3%) pegfilgrastim-cbqv, 25 (3%) pegfilgrastim-jmdb, 23 (3%) filgrastim, 16 (2%) filgrastim-sndz, 5 (< 1%) tbo-filgrastim, and 3 (< 1%) combination... The most common chemotherapy agents included cyclophosphamide, carboplatin, doxorubicin, docetaxel, or pertuzumab. Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products."

Clinical • Breast Cancer • Oncology • Solid Tumor • CSF3

A Retrospective Analysis of Prophylactic G-CSF Biosimilar and Originator Administrative Claims over Time Among Patients with Non-Hodgkin Lymphoma (ASH 2022) - "Of 2,094 (81%) patients who received high-risk chemotherapy, 1,919 (92%) received pegfilgrastim, 71 (3%) pegfilgrastim-cbqv, 49 (2%) pegfilgrastim-jmdb, 21 (<1%) filgrastim, 20 (<1%) filgrastim-sndz, and 14 (<1%) tbo-filgrastim or a combination of products...The most common chemotherapy regimens included cyclophosphamide/doxorubicin/vincristine/rituximab (n=1,304), bendamustine/rituximab (n=469), cyclophosphamide/rituximab (n=119), cyclophosphamide/doxorubicin/vincristine (n=105), rituximab (n=101), doxorubicin/vinblastine (n=91), and cyclophosphamide/doxorubicin/etoposide/vincristine/rituximab (n=46)...Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products."

Retrospective data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CSF3

An exploratory comparative effectiveness analysis of febrile neutropenia incidence among patients with cancer receiving granulocyte colony stimulating factors. (ASCO-QC 2022) - " A total of 15,941 patients received a pegfilgrastim product in cycle 1 of chemotherapy: 15,115 (95%) pegfilgrastim, 484 (3%) pegfilgrastim_cbqv, 342 (2%) pegfilgrastim_jmdb. We observed no significant difference in FN incidence among patients when comparing various G-CSF products, including when biosimilars were compared to their reference counterparts."

HEOR • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CSF3

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (clinicaltrials.gov) - P3; N=987; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; Initiation date: Nov 2019 ➔ Jul 2019

Clinical • Enrollment open • Trial initiation date • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Rheumatoid Arthritis

Patient out-of-pocket and payer costs for pegfilgrastim originator vs biosimilars as primary prophylaxis of febrile neutropenia in the first cycle among a commercially insured population. (PubMed, J Manag Care Spec Pharm) - " A total of 1,930 patients were included, of whom 884 (45.8%) used pegfilgrastim originator, 427 (22.1%) used pegfilgrastim-jmdb, and 619 (32.1%) used pegfilgrastim-cbqv... In a commercially insured population, using pegfilgrastim biosimilars in the first cycle for primary prophylaxis of FN led to cost savings for patients but not payers. No difference in FN-related costs was observed."

Journal • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology

Lower out-of-Pocket Costs Associated with Pegfilgrastim Biosimilars (ISPOR 2022) - "This study compared medical costs including pegfilgrastim drug costs and febrile neutropenia (FN)-related costs between pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-cbqv) and originator users. In a commercially insured population, using pegfilgrastim biosimilars led to cost-savings for patients, but not payers. No difference in FN treatment costs was observed."

Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology

Real-World Comparative Effectiveness of Pegfilgrastim Biosimilars Versus Originator (ISPOR 2022) - "This study compared the incidence of febrile neutropenia (FN) between pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-cbqv) and originator users. In this real-world study of patients with cancer receiving myelosuppressive chemotherapy, there was no difference in FN risk between patients receiving pegfilgrastim originator and biosimilars in the first cycle."

Clinical • HEOR • Real-world evidence • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Solid Tumor • Transplantation

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (clinicaltrials.gov) - P3; N=249; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P3 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

"Lay low😉He might make fun of how a disproportionately large number of medications start with X or Z, the ridiculous names of medications like Moxetumomab pasudotox (Lumoxiti), Tagraxofusp (Elzonris), or nonsense suffixes like Pegfilgrastim-cbqv / jmdb (Udenyca/Fulphila)" (@Hem_Onc)

FDA’s naming rule for biosimilars has undermined Congress and health care (STAT) - "I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my patients. This is a drug that helps prevent fever and infection associated with low white blood cell counts. For years, prescribing it has been simple, since the only option was the brand-name drug, Neulasta brand pegfilgrastim....Nevertheless, the FDA now requires all biologics to bear a four-letter suffix in addition to the generic name which would identify it to regulators. There are no data comparing one biosimilar to another, so physicians and pharmacists must assume it works as well as the others....Is it any wonder the advent of biosimilars has not resulted in the anticipated savings to the health care system? This week I was able to finally get pegfilgrastim-cbqv (Udenyca) approved for my patient and covered by the patient’s insurance, but only after multiple phone calls with the insurer. Now I can only hope it will be delivered in time."

Online posting

[VIRTUAL] Cost-efficiency analysis of conversion from reference pegfilgrastim to its biosimilar (pegfilgrastim-jmdb) and expanded access to food and transportation support for Medicare/Medicaid patients within the CMS Oncology Care Model. (ASCO 2021) - "Savings from biosimilar conversion can be re-allocated on a budget neutral basis to food and transportation support to pts with such needs . This achieves the dual OCM aim of reducing drug budgets while enhancing patient-centric support services."

CMS • Medicaid • Medicare • Oncology care model • Reimbursement • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Investigators Measure Pegfilgrastim Biosimilar Savings Potential (Center for Biosimilars) - "Whether or not estimated failure rates of the pegfilgrastim onbody injector (OBI; Onpro, Neulasta) are factored in, pegfilgrastim biosimilars have the potential to generate significant savings, investigators found in a model simulation analysis. Their study evaluated the potential savings of the pegfilgrastim biosimilar Fulphila used as prophylaxis treatment against chemotherapy-induced neutropenia (CIN)."

Commercial • Neutropenia

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P1 trial • Diffuse Large B Cell Lymphoma • Human Immunodeficiency Virus • Infectious Disease • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Sep 2020 ➔ Jul 2023; Trial primary completion date: Sep 2020 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; Trial primary completion date: Jul 2023 ➔ Sep 2021

Clinical • Enrollment open • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Clinical • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Clinical • Trial suspension • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; Trial primary completion date: May 2019 ➔ Sep 2020

Clinical • Enrollment open • Trial primary completion date • Diffuse Large B Cell Lymphoma • Human Immunodeficiency Virus • Infectious Disease • CD20 • CD4