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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.
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.
Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator
December 11th 2024Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.
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.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
