DURHAM, North Carolina — The US Food and Drug Administration approved ENNUMO, Accord BioPharma's granulocyte colony-stimulating factor biosimilar, on Wednesday. The drug reduces infection risk in patients undergoing chemotherapy.

ENNUMO boosts white blood cell production in cancer patients whose immune systems are weakened by cytotoxic therapy. The therapeutic class has long been dominated by reference biologics such as Amgen's Neupogen.

Accord, the US specialty arm of India's Intas Pharmaceuticals, has publicly stated it aims to launch 20 biosimilars over the coming years. The strategy is intended to widen patient access and reduce treatment costs across oncology, immunology and supportive care markets in the United States.

Biosimilars are near-identical versions of complex biologic medicines and have become a central tool for US payers and hospitals seeking to control drug spending. The Association for Accessible Medicines estimated that biosimilars saved the American health system billions of dollars in recent years, though uptake has varied by therapeutic area.

Analysts tracking the biosimilar sector said the ENNUMO approval added competitive pressure in the supportive-care segment, where several filgrastim and pegfilgrastim products already compete on price. Accord said it would provide launch timing and pricing details in due course.