FDA Approves Ennumo; Accord BioPharma Expands G-CSF Portfolio

The FDA has approved Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta, for use in adult and pediatric patients to reduce the incidence of febrile neutropenia and increase survival after radiation exposure. This regulatory milestone establishes Accord BioPharma as a dominant player in the supportive care market, holding the largest single-company G-CSF biosimilar portfolio in the world. The approval comes alongside significant industry movement, including a $150 million merger between Chemomab and Scipher Medicine and a strategic licensing deal between Teva and Polpharma Biologics.

The FDA's approval of Ennumo (pegfilgrastim-pccg) marks a significant expansion for Accord BioPharma, making it the only company in the United States to offer two distinct pegfilgrastim biosimilars alongside a short-acting G-CSF biosimilar, Filkri. Ennumo is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy and to improve survival in those acutely exposed to myelosuppressive radiation doses. This portfolio allows Accord to address both long-acting and short-acting supportive care needs across oncology practices and hospitals, leveraging a lineup the company describes as the most comprehensive in the global G-CSF biosimilar market.

In a major consolidation move, Chemomab Therapeutics and Scipher Medicine have entered a definitive merger agreement valued at $150 million pre-transaction. The combined entity will focus on advancing Chemomab's first-in-class anti-CCL24 antibody, nebokitug, through an AI-guided Phase II trial for rheumatoid arthritis (RA). The merger utilizes Scipher's AI Network Medicine platform to target a disease where the last novel mechanism drug was approved over a decade ago. Backed by a $30 million private placement, the new company expects a cash runway into the second half of 2028, with Scipher shareholders owning approximately 68 percent of the entity.

Further shifting the biosimilar landscape, Teva Pharmaceuticals International has signed a global licensing agreement with Polpharma Biologics for exclusive commercialization rights to a proposed biosimilar for Ocrevus. This deal covers both intravenous and subcutaneous formulations, positioning Teva to compete in the multiple sclerosis market as Ocrevus approaches its loss of exclusivity. These developments coincide with a broader industry shift toward specialty therapies, which are projected to account for 70 percent of new drug launches through 2027. According to Alina Chesnokova of Cencora, the increasing reliance on cold chain-dependent biologics is forcing manufacturers to move away from fragmented, multi-vendor commercialization models to ensure supply chain integrity.