Gland Pharma, a Indian pharmaceutical company, has achieved a significant milestone with the approval of Plerixafor Injection by the United States Food and Drug Administration (USFDA). The approved product, Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial, is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL (plerixafor) injection, manufactured by Genzyme Corporation, a Sanofi Company.
Plerixafor Injection is a hematopoietic stem cell mobilizer indicated for use 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. This approval represents a significant advancement in providing treatment options for patients with these conditions.
The company anticipates launching the product in the United States market through its marketing partner within the financial year 2025. According to data from IQVIA, a leading healthcare analytics firm, the product recorded approximately USD 152 million in sales in the United States for the twelve months ending January 2024, indicating a substantial market opportunity for Gland Pharma.
The approval from USFDA underscores Gland Pharma’s commitment to delivering high-quality pharmaceutical products and expanding its presence in key global markets. With this approval, the company further solidifies its position as a reliable provider of innovative and essential healthcare solutions to patients worldwide.
Gland Pharma remains dedicated to advancing its pipeline of products and leveraging strategic partnerships to address unmet medical needs and improve patient outcomes across various therapeutic areas.
