The FDA has approved the eighth pegfilgrastim biosimilar; now Accord BioPharma owns two of them: newly approved Ennumo and Udenyca

Accord BioPharma and its parent company Intas Pharmaceuticals announced that had it received approval on July 9th for a new pegfilgrastim biosimilar, which it has dubbed Ennumo (pegfilgrastim-pccg). The new biosimilar has been approved for all of the indications of the reference product Neulasta.

Why Two Pegfilgrastims?

What makes this approval interesting is that Accord and Intas already have a pegfilgrastim biosimilar, the product Udenyca, which is the number 2 pegfilgrastim product as of the end of 2025 (according to IQVIA). Udenyca was approved in 2018 by the FDA, and Accord acquired Udenyca once the original manufacturer, Coherus, decided to exit the biosimilar market. In the press release announcing the newest approval, Accord stated that it now has three separate granulocyte colony-stimulating factor, and “two distinct pegfilgrastim biosimilars” in its portfolio.

BR&R contacted Accord regarding how they intend to differentiate the two pegfilgrastim biosimilars. At present, Udenyca is available as both an injectable and in on-body injector forms. The new biosimilar Ennumo is available in the injectable form only. Otherwise, there is no difference in terms of dosing or indication. While Accord did not respond in time for publication, it may be possible that Accord intends to stop marketing Udenyca as an injectable, allowing Ennumo to take its place, or potentially selling only one brand or the other to certain segments of the US audience.

“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.”

However, it is not yet clear how the additional pegfilgrastim biosimilar improves access. Overall, eight pegfilgrastim biosimilars are marketed today, in addition to the reference product.   

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.