PEGFILGRASTIM Pharmacologic Class Indexing
- Class set ID
- 3da93df4-dfe4-439c-bca5-b2817a0811f1
- Version
- 3
- Effective date
- 20231115
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use NYVEPRIA safely and effectively. See full prescribing information for NYVEPRIA. NYVEPRIA™ (pegfilgrastim-apgf) injection, for subcutaneous use Initial U.S. Approval: 2020 NYVEPRIA (pegfilgrastim-apgf) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe | Pfizer Laboratories Div Pfizer Inc | Hospira Zagreb d.o.o. | Pfizer Inc | 20260602 | 9 |
| These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO ® (pegfilgrastim-bmez) injection, for subcutaneous use Initial U.S. Approval: 2019 ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA ® (pegfilgrastim). | Sandoz Inc | 20260514 | 22 |
| These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA. UDENYCA ® (pegfilgrastim-cbqv) injection, for subcutaneous use INITIAL U.S. APPROVAL: 2018 UDENYCA (pegfilgrastim-cbqv) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful difference | Accord BioPharma, Inc. | 20260423 | 4 |
| These highlights do not include all the information needed to use ARMLUPEG safely and effectively. See full prescribing information for ARMLUPEG. ARMLUPEG (pegfilgrastim-unne) injection, for subcutaneous use Initial U.S. Approval: 2025 ARMLUPEG (pegfilgrastim-unne) is biosimilar* to NEULASTA (pegfilgrastim) (1) | Lupin Pharmaceuticals, Inc. | Lupin Limited | 20260401 | 5 |
| These highlights do not include all the information needed to use NEULASTA safely and effectively. See full prescribing information for NEULASTA. NEULASTA ® (pegfilgrastim) injection, for subcutaneous use Initial U.S. Approval: 2002 | Amgen, Inc | Amgen Manufacturing Limited LLC | 20260310 | 159 |
| These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND ® (pegfilgrastim-fpgk) injection, for subcutaneous use Initial U.S. Approval: 2022 STIMUFEND (pegfilgrastim-fpgk) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful di | NORTHSTAR RX LLC | Merck Biodevelopment, Martillac | FUJIFILM Diosynth Biotechnologies UK Ltd. | Merck Serono S.p.A (MS-Bari) | Merck Serono S.p.A (MS-Guidonia) | Istituto di Ricerche Biomediche Antoine marxer RBM S.P.A | Fresenius Kabi USA, LLC | Fresenius Kabi Austria GmbH | 20251130 | 1 |
| These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA. UDENYCA ® (pegfilgrastim-cbqv) injection, for subcutaneous use INITIAL U.S. APPROVAL: 2018 UDENYCA (pegfilgrastim-cbqv) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful difference | Coherus Oncology, Inc. | 20250814 | 13 |
| These highlights do not include all the information needed to use FYLNETRA safely and effectively. See full prescribing information for FYLNETRA . FYLNETRA ® (pegfilgrastim-pbbk ) injection, for subcutaneous use Initial U.S. Approval: 2022 FYLNETRA (pegfilgrastim-pbbk) is biosimilar* to NEULASTA (pegfilgrastim). | Amneal Pharmaceuticals LLC | Kashiv BioSciences, LLC | 20250425 | 8 |
| These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for FULPHILA. FULPHILA ® (pegfilgrastim-jmdb) injection, for subcutaneous use Initial U.S. Approval: 2018 FULPHILA ® (pegfilgrastim-jmdb) is biosimilar* to NEULASTA ® (pegfilgrastim). (1) | Biocon Biologics Inc. | Biocon Biologics Limited | 20231205 | 10 |
| These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND ® (pegfilgrastim-fpgk) injection, for subcutaneous use Initial U.S. Approval: 2022 STIMUFEND (pegfilgrastim-fpgk) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful di | Fresenius Kabi USA, LLC | Merck Biodevelopment, Martillac | FUJIFILM Diosynth Biotechnologies UK Ltd. | Merck Serono S.p.A (MS-Bari) | Merck Serono S.p.A (MS-Guidonia) | Istituto di Ricerche Biomediche Antoine marxer RBM S.P.A | Fresenius Kabi Austria GmbH | 20231024 | 4 |