This latest regulatory clearance solidifies Accord BioPharma’s position as the only U.S. provider offering two distinct pegfilgrastim biosimilars, alongside its existing short-acting filgrastim option. By adding ENNUMO to its portfolio, the company aims to offer oncology practices more flexibility in managing febrile neutropenia, a frequent and dangerous complication of chemotherapy that often leads to treatment delays and hospitalizations.
Accord BioPharma Secures FDA Approval for ENNUMO Biosimilar
The U.S. Food and Drug Administration has approved ENNUMO, a biosimilar to Neulasta, marking a strategic expansion for Accord BioPharma. The drug is indicated for pediatric and adult patients to reduce infection risks during myelosuppressive chemotherapy and to treat patients exposed to myelosuppressive radiation doses.
Chrys Kokino, President of Accord North America, stated that the company remains on track to deliver 20 biosimilar products by 2030. The firm, a division of Intas Pharmaceuticals, is leveraging its parent company's five decades of experience to build a comprehensive suite of supportive care therapies. According to Nuvan Dassanaike, Senior Vice President of Digital and Marketing Strategy, the goal is to address the varied clinical needs of hospitals and clinics by providing a broader range of options for patient care.
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