Gland Pharma Receives US-FDA Nod for Plerixafor Injection, Expanding Oncology Portfolio

Gland Pharma Limited (Gland), a leading generic injectable-focused pharmaceutical company, has secured significant approval from the United States Food and Drug Administration (USFDA) for its Plerixafor Injection. This marks a strategic expansion of Gland’s oncology portfolio within the crucial US market.

Approved Product Details

The USFDA-approved Plerixafor Injection is available in a 24 mg/1.2 mL (20 mg/mL) single-dose vial format. Crucially, the product is designated as both bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL® (plerixafor) injection, manufactured by Genzyme Corporation, a Sanofi Company.

Therapeutic Application

Plerixafor Injection falls within the category of hematopoietic stem cell mobilisers. This medication is indicated for use in combination with filgrastim to mobilise hematopoietic stem cells (HSCs) into the peripheral blood for subsequent collection and autologous transplantation. This process plays a vital role in treating patients with non-Hodgkin’s lymphoma and multiple myeloma, offering them potentially life-saving options.

Market Potential and Launch Strategy

Gland anticipates launching the Plerixafor Injection within the current fiscal year (FY25) through its established marketing partner. Market research firm IQVIA estimates that the product garnered approximately USD 152 million in sales within the US market for the twelve months ending January 2024. This significant market size underscores the potential for Gland to gain a strong foothold in this therapeutic segment.

Strategic Significance

The USFDA approval for Plerixafor Injection represents a major milestone for Gland Pharma. This approval not only broadens Gland’s oncology product portfolio but also strengthens its presence within the high-growth US market. By offering a bioequivalent and therapeutically equivalent generic alternative, Gland contributes to patient access to critical oncology treatments while potentially generating significant revenue streams.

Looking Ahead

Gland’s successful acquisition of USFDA approval for Plerixafor Injection signifies the company’s commitment to developing and delivering high-quality generic injectable medications for patients worldwide. With its upcoming launch through a trusted partner and substantial market potential, this product is poised to contribute significantly to Gland’s future growth trajectory.

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