Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (Product). The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL (plerixafor) injection of Genzyme Corporation, a Sanofi Company.
The Product is a hematopoietic stem cell mobilizer indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.
The Company expects to launch this Product through its marketing partner within FY25. According to IQVIA, the product had US sales of approximately $152 million for the twelve months ending January 2024.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
