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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.
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How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
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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.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
