In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.
In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application (BLA) for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.
Eflapegrastim, which the company hopes to sell under the brand name Rolontis, comprises 2 proteins: an analog of G-CSF and an Fc antibody fragment. These components are joined by a polyethylene-glycol linker. According to the company, the Fc fragment is thought to interact with FcRn—expressed in endothelial cells and bone marrow—and to prolong the drug’s retention in these tissues.
“If approved, Rolontis could be the first novel [G-CSF] available to healthcare providers in over 15 years,” said the company’s chief executive officer, Joe Turgeon, in a statement. “We have confidence in the future of Rolontis and are looking forward to potentially competing in this multibillion-dollar market.”
The company expects a decision from the FDA by October 24, 2020.
The drug was studied in comparison with pegfilgrastim a phase 3, randomized, open-label trial in 237 patients with breast cancer who were receiving chemotherapy. Patients were randomized to receive either the investigational drug (n = 118) or pegfilgrastim (n = 119), and the primary end point was the duration of severe neutropenia in cycle 1 of chemotherapy as measured by absolute neutrophil count.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
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.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Long-Term Data Support Use of Eculizumab Biosimilar as Soliris Alternative in PNH
January 28th 2025Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.