FDA Approves Gland Pharma's Plerixafor Injection

In a significant step for the pharmaceutical industry, Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial. This development marks a pivotal moment for the company, as it expands its portfolio of generic injectables and offers new hope to patients in need.

Plerixafor Injection is a hematopoietic stem cell mobilizer, used 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 process is critical for these patients, as it prepares them for stem cell transplant, a crucial step in their treatment journey.

The USFDA's approval for Gland Pharma's Plerixafor Injection comes after rigorous testing and evaluation, ensuring the product's bioequivalence and therapeutic equivalence to the reference listed drug (RLD), Mozobil (plerixafor) injection of Genzyme Corporation, a subsidiary of Sanofi. This achievement underscores Gland Pharma's commitment to providing high-quality, accessible treatments to patients worldwide.

Gland Pharma expects to launch the Plerixafor Injection through its marketing partner by FY25, with the product having had US sales of approximately USD 152 million. This strategic move not only strengthens Gland Pharma's position in the global pharmaceutical market but also promises to make a significant impact on the lives of patients battling lymphoma and multiple myeloma.

This approval from the USFDA is a testament to Gland Pharma's dedication to research, innovation, and quality assurance. As the company continues to expand its offerings and develop new treatments, it remains focused on improving patient outcomes and contributing to the advancement of healthcare worldwide.