Accord BioPharma has secured US FDA approval for ENNUMO (pegfilgrastim-pccg), a biosimilar to NEULASTA (pegfilgrastim), strengthening the company’s position in the rapidly expanding biosimilar market for cancer supportive care.

 

The approval makes Accord BioPharma the only company in the US offering two pegfilgrastim biosimilars — ENNUMO and UDENYCA (pegfilgrastim-cbqv) — along with FILKRI (filgrastim-laha), a short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar. 

 

Together, the three therapies create what the company describes as the broadest G-CSF biosimilar portfolio available from a single US biosimilar manufacturer.

 

ENNUMO is approved for the same indications as its reference product, NEULASTA, including reducing the risk of infection caused by febrile neutropenia in adults and pediatric patients receiving myelosuppressive anticancer treatments. 

 

The therapy is also approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation associated with Hematopoietic Subsyndrome of Acute Radiation Syndrome.

 

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," said Chrys Kokino, President, Accord North America. 

 

"With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings. Most importantly we are proud that we have and will continue to increase patient access to these critically important medicines."

 

Febrile neutropenia remains one of the most serious complications associated with myelosuppressive chemotherapy, potentially leading to treatment delays, dose reductions, hospitalizations, and increased mortality risk among cancer patients. G-CSF therapies play a central role in helping protect patients during cancer treatment by supporting white blood cell recovery.

 

Accord BioPharma said the addition of ENNUMO reflects its strategy of providing healthcare providers with multiple treatment options to address different clinical and operational needs.

 

"From speaking with our customers, we know the needs of oncology practices are not one-size-fits-all, and we've built our portfolio to address this reality," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. 

 

"With ENNUMO and UDENYCA, we have pegfilgrastim biosimilar options to offer—alongside FILKRI for short-acting G-CSF—so we can meet physicians and their patients where they are."

 

The ENNUMO approval advances Accord BioPharma’s goal of launching 20 biosimilar products in the U.S. by 2030. The company’s portfolio currently spans oncology and immunology therapies, with plans to expand further into central nervous system treatments.

 

Backed by Intas Pharmaceuticals, one of the world’s largest biosimilar developers, Accord BioPharma is leveraging decades of pharmaceutical development experience to expand access to biologic medicines.

 

"ENNUMO's approval is another proof point that what we're building at Accord BioPharma can genuinely change the treatment landscape for patients in the U.S.," said Binish Chudgar, Chairman and Managing Director, Intas Pharmaceuticals. "Our goal of 20 biosimilars by 2030 is not just a number. It reflects the depth of our pipeline and our determination to deliver."