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Spectrum Gears Up To File Rolontis, Stresses Patient Access

 
• By Emily Hayes

Biosimilars of Amgen's blockbuster Neulasta pose a competitive threat to long-acting GSF Rolontis, but the company has experience with group purchasing and notes that large oncology clinics will make more revenue by providing higher-priced products.

Healthcare Business and Medical Services Concept

Spectrum Pharmaceuticals Inc. stressed its ability to offer access to its novel long-acting granulocyte colony stimulating factor (G-CSF) Rolontis, through patient assistance programs, based on positive data from two Phase III studies – ADVANCE and RECOVER – that pave the way for a biologic license application (BLA) filing in the fourth quarter.

Rolontis (eflapegrastim, SPI-2012) is being positioned to take on the market of Amgen Inc.'s blockbuster Neulasta (pegfligrastim) for the prevention of neutropenia in patients undergoing chemotherapy. Neulasta has been the only long-acting GSF on the market, but biosimilars are on the way. The FDA approved Mylan NV/Biocon Ltd.'s pegfilgrastim biosimilar Fulphila (pegfilgrastim-jmdb) in June

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