Gland Pharma gets USFDA nod for Plerixafor and Edaravone injection, anticipates launch in FY25

Gland Pharma, a generic injectables pharmaceutical company, received approval from the United States Food and Drug Administration (USFDA) for Plerixafor and Edaravone injections. Shares of the company were trading over 1% higher on Tuesday.

Plerixafor injection is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL (plerixafor) injection of Genzyme Corporation, a subsidiary of Sanofi. Edaravone injection is bioequivalent and therapeutically equivalent to the Radicava injection of Mitsubishi Tanabe Pharma Corporation.

Gland Pharma said that Plerixafor is a hematopoietic stem cell mobiliser indicated in combination with filgrastim to mobilise hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation for patients diagnosed with non-Hodgkin's lymphoma or multiple myeloma.

Edaravone is used in the treatment of amyotrophic lateral sclerosis (ALS), a neuro-degenerative disorder characterised by the gradual degeneration of the nerves responsible for controlling muscle movement. This degeneration leads to muscle atrophy and weakness.

Gland Pharma said it anticipates the launch of Plerixafor and Edaravone injections through its marketing partner within the fiscal year 2025. According to IQVIA data, Plerixafor injection recorded US sales of approximately $152 million for the twelve months ending January 2024 while sales of Edaravone injection amounted to approximately $19 million for the twelve months ending January 2024.

Established in 1978 in Hyderabad, Gland Pharma evolved from a contract manufacturer of small-volume liquid parenteral products to become an injectable-focused company. The firm has a presence in over 60 countries, including markets such as the United States, Europe, Canada, Australia, and India.

Operating primarily under a business-to-business (B2B) model, Gland Pharma is involved in the development, manufacturing, and marketing of sterile injectables. Its product portfolio spans a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilised vials, dry powders, infusions, oncology, and ophthalmic solutions.

Shares of the company have lost over 10% since the beginning of the year. The stock has risen over 24% in the last one year.