FDA Approves Accord BioPharma's ENNUMO Biosimilar to Neulasta

The approval expands Accord BioPharma's oncology supportive care portfolio, making it the only US company to offer two pegfilgrastim biosimilars alongside a filgrastim biosimilar.

Accord BioPharma has received US Food and Drug Administration (FDA) approval for ENNUMO (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim), strengthening the company's position in the growing biosimilars market.

The approval gives Accord BioPharma what it describes as the most comprehensive granulocyte colony-stimulating factor (G-CSF) biosimilar portfolio in the United States, adding ENNUMO alongside its existing pegfilgrastim biosimilar UDENYCA and short-acting filgrastim biosimilar FILKRI.

Expanding Supportive Care Options in Oncology

ENNUMO has been approved for the same indications as the reference product, Neulasta.

The biosimilar is indicated to reduce the incidence of febrile neutropenia in adults and children receiving myelosuppressive chemotherapy for non-myeloid cancers, as well as to improve survival following exposure to myelosuppressive doses of radiation associated with Hematopoietic Subsyndrome of Acute Radiation Syndrome.

Febrile neutropenia is one of the most common and serious complications associated with cancer treatment, often leading to hospitalisation, treatment delays and chemotherapy dose reductions.

G-CSF therapies help stimulate white blood cell production, reducing the risk of infection in patients undergoing chemotherapy.

Building a Broader Biosimilar Portfolio

With ENNUMO's approval, Accord BioPharma now offers:

• ENNUMO (pegfilgrastim-pccg) – long-acting G-CSF biosimilar

• UDENYCA (pegfilgrastim-cbqv) – long-acting G-CSF biosimilar

• FILKRI (filgrastim-laha) – short-acting G-CSF biosimilar
  

The company says the expanded portfolio allows healthcare providers greater flexibility when selecting supportive care options for oncology patients across different clinical settings.

Long-Term Biosimilar Growth Strategy

The approval represents another milestone in Accord BioPharma's broader expansion strategy.

The company aims to launch 20 biosimilars in the US by 2030, building its presence across oncology, immunology and, eventually, central nervous system (CNS) therapies.

Accord BioPharma is the US specialty division of Intas Pharmaceuticals, one of the world's largest biosimilar developers.

Company executives said expanding access to high-quality, lower-cost biologic medicines remains central to its long-term strategy.

Why the Approval Matters

The approval reflects several broader trends across the healthcare market:

• Biosimilars continue to increase competition within oncology supportive care.

• Larger biosimilar portfolios are giving healthcare providers greater treatment flexibility.

• Expanding biosimilar availability could improve patient access while helping reduce healthcare costs.

• Oncology supportive care remains a key area for biosimilar adoption as chemotherapy use continues to grow.
  

Summary

The FDA has approved Accord BioPharma's ENNUMO, a biosimilar to Neulasta, for the prevention of febrile neutropenia and treatment following radiation exposure.

The approval strengthens Accord BioPharma's oncology portfolio, making it the only company in the US to offer two pegfilgrastim biosimilars alongside a filgrastim biosimilar as it pursues its goal of launching 20 biosimilars by 2030.

---

Discover how nuaxia can support your next medical education initiative:

• Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector 

• Contact us on: support@nuaxia.com