Oncology

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

Investigators produced what they described as the first evidence supporting the use of biosimilar erythropoiesis-stimulating agents (ESAs) in patients with myelofibrosis-related anemia.

Canada Health has approved the launch of Sandoz' pegfilgrastim and rituximab biosimilars.

Biosimilar discounts to reference products have improved over time, but they are deeper in some categories than others.

As part of pilot program designed to improve access to cheaper medications in oncology, a rituximab biosimilar from Celltrion has been approved for use by the World Health Organization (WHO).

Recognizing that oncology practices are struggling with the pandemic, the Center for Medicare and Medicaid Innovation has eased some performance requirements.

Here is a summary of our coverage from ASCO20 Virtual, the annual meeting for the American Society of Clinical Oncology (ASCO).

Clinical trials leading up to biosimilar approval may not reveal the full safety and efficacy profile of biosimilars vs reference products, and postmarketing studies may be essential to elucidate any differences, investigators said.

A real-world study helped show how pegfilgrastim biosimilar can improve savings in the Oncology Care Model and its successor, the Oncology Care First Model, according to findings presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.

Switching patients with cancer to biosimilar pegfilgrastim for prophylaxis treatment of chemotherapy-induced febrile neutropenia could generate significant savings for adjuvant treatment, investigators found in studies presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).

Shanghai Henlius Biotech received a positive European review opinion for its trastuzumab biosimilar HLXO2 and anticipates marketing authorization in 2 to 3 months.

When used as a primary prophylaxis, biosimilar filgrastim (Zarxio) was found to be cost-effective when used to treat patients with nonmetastatic non–small cell lung cancer (NSCLC), according to a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).

The rituximab biosimilar candidate ABP 798 met primary and secondary end points for safety, efficacy, and immunogenicity in a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).

Cancer drug prices are rising in the United States and Europe, but European regulators negotiate drug prices, and the results are seen in pricing trends, investigators said in a presentation at the American Society of Clinical Oncology.

Devika Das, MBBS, reviews the evidence presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology, and concludes that some deep reforms are needed in oncology care to improve access.

Abstracts presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology, revealed important data on physician prescribing of biosimilars and cost savings in the oncology space.

Prestige BioPharma of Singapore has successful clinical trials to support its bid to market a trastuzumab, based on findings presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.

A study presented at ASCO20 Virtual demonstrated the power of biosimilar pegfilgrastim to lower costs in the Oncology Care Model (OCM), where pegfilgrastim expense amounts to 5.3% of the total cost of cancer care.

Fresenius Kabi has tapped pharmaceuticals distribution company medac to amplify sales of its pegfilgrastim biosimilar in Germany.

Despite the United States’ slow start in biosimilar uptake, history shows that things can change, according to Michael Kolodziej, MD, who presented at the National Comprehensive Cancer Network (NCCN) 2020 Virtual Conference.

Fresenius Kabi USA announced that the FDA has accepted its biologics license application for the pegfilgrastim biosimilar candidate MSB11455.

Ali McBride, PharmD, MS, BCOP, clinical coordinator of Hematology and Oncology in the Department of Pharmacy at the University of Arizona Cancer Center and past president of the Association of Community Cancer Centers (ACCC), discusses physician struggles tied to biosimilar utilization, the upcoming initiatives for the ACCC Biosimilars Center, and why physicians should be keeping an eye on biosimilars.

Ruth O’Regan, of the University of Wisconsin Carbone Cancer Center, discusses improving the patient discussion on biosimilars, in an interview.

On the heels of positive clinical studies, Fresenius Kabi said the European Medicines Agency will review its product application for a pegfilgrastim biosimilar.