PEGFILGRASTIM BIOSIMILARS MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

Pegfilgrastim Biosimilars Market, By Product (Pegfilgrastim Biosimilars and Pegfilgrastim Reference Product), By Application (Oncology, Chronic Neutropenia, Stem Cell Transplantation, Others), By Route of Administration (Subcutaneous and Intravenous), By Distribution Channel (Hospitals Pharmacies, Retail Pharmacies, Online Pharmacies), By Geography (North America, Latin America, Europe, Asia Pacific, Middle East & Africa)

In December 2023, The U.S. FDA approved Udencya Onbody, an on-body injector for the biosimilar pegfilgrastim-cbqv (Udencya). This device is used to reduce febrile neutropenia risk in cancer patients the day after chemotherapy. Approval was based on extensive data, including pharmacokinetics and bioequivalence studies. Coherus BioSciences plans to launch Udencya Onbody in Q1 2024.
In May 2023, Amneal Pharmaceuticals launched FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Neulasta in a pre-filled syringe. Developed with Kashiv Biosciences, FYLNETRA is used to treat neutropenia in chemotherapy patients. The product has received an approved J-Code (Q5130) from CMS.
In June 2020, Pfizer Inc. announced that the USFDA had approved NYVEPRIA (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). NYVEPRIA is indicated to reduce the risk of febrile neutropenia in patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy.
In December 2023, Coherus BioSciences, Inc. announced that the FDA had approved UDENYCA ONBODY, an on-body injector for UDENYCA (pegfilgrastim-cbqv). This pegfilgrastim biosimilar, administered after chemotherapy, helps reduce the incidence of febrile neutropenia.