Biocon Pharma Gets US FDA Approval for Generic Everolimus

Biocon Pharma, a subsidiary of Biocon Ltd, has received approval from the United States Food and Drug Administration (US FDA) for its generic everolimus tablets for oral suspension. The approval was granted under an Abbreviated New Drug Application (ANDA) and covers three dosage strengths—2 mg, 3 mg, and 5 mg. The clearance allows the company to market the product in the US, strengthening its position in the US generics market.

Everolimus is used in the treatment of tuberous sclerosis complex (TSC), a rare genetic disorder that causes non-cancerous tumors to develop in multiple organs, including the brain, kidneys, heart, lungs, and skin. TSC often appears in early childhood and can lead to long-term neurological complications if not properly managed.

The FDA-approved product is indicated for the treatment of adult and paediatric patients aged one year and above with subependymal giant cell astrocytoma (SEGA), a brain tumor commonly associated with TSC. It is also approved as an adjunctive therapy for partial-onset seizures in patients aged two years and older who have seizures linked to TSC.

With this approval, Biocon Pharma expands its portfolio of complex generics and specialty products for chronic and rare conditions. The company follows a vertically integrated pharmaceutical model, covering development, manufacturing, and commercialization, which supports consistent quality and regulatory compliance.

The approval is expected to improve access to affordable generic medicines in the US, where branded everolimus therapies are often associated with high costs. Generic alternatives play an important role in reducing treatment expenses for patients and healthcare systems, particularly for conditions that require long-term therapy.

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Biocon Pharma continues to focus on regulated markets, with the US remaining a key growth area. The latest approval adds to its pipeline of specialty generics aimed at addressing unmet medical needs while maintaining competitive pricing and reliable supply.