Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for plerixafor injection single-dose vial product.
The product is bio-equivalent and therapeutically equivalent to the reference listed drug Mozobil (plerixafor) from Genzyme Corporation, a Sanofi company.
It is a haematopoietic stem cell mobiliser indicated in combination with filgrastim to mobilise haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma or multiple myeloma.
The Hyderabad-based company expects to launch the product through its marketing partner in FY25. According to IQVIA, the product had US sales of approximately $152 million for the 12 months ending January 2024, a release said.