- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Spectrum Says Its Novel G-CSF Drug Will Be Reviewed by FDA
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.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
