FDA approved Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim), which was developed by Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals.

The approval makes Accord BioPharma the only company in the U.S. offering two distinct pegfilgrastim biosimilars, while also giving the company what it describes as the largest G-CSF biosimilar portfolio in the world from a single biosimilar company.¹

Binish Chudgar, chairman and managing director of parent company Intas Pharmaceuticals, connected the approval to the company's longer-term ambitions. "Our goal of 20 biosimilars by 2030 is not just a number," Chudgar said. "It reflects the depth of our pipeline and our determination to deliver."

What is Ennumo approved for?

Ennumo is approved for the same indications as its reference product, Neulasta, and is indicated in adults and pediatric patients from newborn and older to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Febrile neutropenia is among the most serious and common complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalizations and increased mortality risk in cancer patients.¹ G-CSF therapies have become a cornerstone of oncology supportive care, and biosimilars have played a growing role in expanding access to these treatments across clinical settings.

What is the significance of the approval?

The approval of Ennumo completes a three-product G-CSF lineup for Accord BioPharma. The company already markets Udenyca (pegfilgrastim-cbqv), a long-acting pegfilgrastim biosimilar, and Filkri (filgrastim-laha), a short-acting G-CSF biosimilar approved in February 2026.² Together, the three products are designed to address the range of clinical and operational needs across oncology practices and hospitals.¹

"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 of Digital and Marketing Strategy and Operations at 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."

What is the company saying?

Accord BioPharma framed the approval as a milestone in a broader strategic build-out, as the company has set a target of launching 20 biosimilar products in the U.S. by 2030, expanding a commercial portfolio that currently spans oncology and immunology, with plans to extend into CNS therapies.¹

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," said Chrys Kokino, president of Accord North America. "With Ennumo, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings."

Sources

1. FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar to NEULASTA® (pegfilgrastim) Accord BioPharma July 9, 2026 https://www.prnewswire.com/news-releases/fda-approves-ennumo-pegfilgrastim-pccg-accord-biopharmas-second-pegfilgrastim-biosimilar-to-neulasta-pegfilgrastim-302821209.html
2. FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma's Biosimilar to NEUPOGEN® (filgrastim) Accord BioPharma February 17, 2026 https://www.prnewswire.com/news-releases/fda-approves-filkri-filgrastim-laha-accord-biopharmas-biosimilar-to-neupogen-filgrastim-302689073.html