BDR Pharmaceutical Launches First Generic Apalutamide in India for Prostate Cancer Treatment
Key Insights
BDR Pharmaceutical has launched India's first generic version of apalutamide (brand name Apatide) for treating metastatic castration-sensitive and non-metastatic castration-resistant prostate cancer.
The generic drug is priced at one-third the cost of the innovator brand, with 60 tablets costing Rs 22,500 and 120 tablets costing Rs 45,000.
Clinical data from the SPARTAN trial showed apalutamide plus androgen-deprivation therapy reduced disease progression risk by 71% and improved median progression-free survival from 14.7 to 40.5 months.
BDR Pharmaceutical has launched India's first generic version of apalutamide, marketed under the brand name Apatide, to treat two forms of prostate cancer: metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). The 60 mg strength tablets are available in packs of 60 and 120 tablets across India.
Significant Cost Reduction for Patients
The generic formulation represents a substantial cost reduction for patients, priced at one-third the cost of the innovator brand. According to Raheel Shah, Director Business Development at BDR Group, the 60-tablet pack costs Rs 22,500 while the 120-tablet pack is priced at Rs 45,000.
Clinical Efficacy Data
Clinical evidence from the SPARTAN trial demonstrates the drug's significant therapeutic benefits for patients with nmCRPC. When combined with androgen-deprivation therapy (ADT), apalutamide showed remarkable improvements in patient outcomes. The median progression-free survival for the apalutamide plus ADT arm reached 40.5 months compared to 14.7 months for the placebo plus ADT arm, representing a 71% decrease in the risk of disease progression or death.
For patients with mCSPC, apalutamide in combination with anti-androgen therapy significantly improves survival chances. The treatment also reduces mortality risk by 35% among nmCRPC patients while maintaining overall health-related quality of life as measured by functional assessment tools.
The SPARTAN trial data revealed that apalutamide combined with anti-androgen therapy significantly improved median metastasis-free survival by two years, with patient-reported outcomes indicating maintained overall health-related quality of life.
Addressing India's Prostate Cancer Burden
The launch comes at a critical time as prostate cancer represents a significant health challenge in India, ranking as the second most common cancer and the sixth leading cause of cancer deaths among men. Globally, the prostate cancer burden is projected to reach 1.7 million new cases and 499,000 new deaths by 2030 due to population growth and aging.
Company's Oncology Portfolio
BDR Pharmaceutical has established itself as a key player in Indian cancer medicine manufacturing, with a comprehensive prostate cancer treatment portfolio that includes abiraterone acetate, leuprolide acetate, enzalutamide, degarelix, and triptorelin. The company focuses on four specialized therapeutic segments: oncology, critical care, gynecology, and neurology.
"Early identification of newer molecules for life-threatening diseases encourages us to advance the development and introduction of products through the strength of backward integration of developing and manufacturing APIs," Shah stated. The company emphasizes its commitment to providing affordable medicines without compromising patient safety or quality standards, supporting India's vision of pharmaceutical self-reliance.