Glenmark Pharma announced the launch of generic version of Nintedanib (Nindanib), used for the treatment of pulmonary fibrosis in India.
Glenmark being a leader in the area of respiratory has been amongst the first to launch the branded generic version at an affordable cost for the treatment of pulmonary fibrosis in India.
This will provide patients a far more cost effective treatment option, and enable doctors to treat a wider patient population in the country.
Glenmark’s Nindanib priced at Rs. 4,500 (100 mg) and Rs. 5,400 (150 mg) per month is just available at 5% of the cost as compared to the innovator brand in India.
Nintedanib is approved by the Indian drug regulator for the treatment of Idiopathic (unknown cause) pulmonary fibrosis (IPF).
"Since IPF is a progressive disease that gets worse over time, starting treatment early and continuing treatment are important to slow disease progression.
"A lower monthly treatment cost therefore becomes crucial to ensure patients adhere to prescribed treatment in the long term. So far, Nintedanib has been studied extensively in various controlled clinical trials that have established its efficacy and safety," the company added.
Glenmark said two clinical trials are being rolled out to study the efficacy and safety of Nintedanib as a treatment of SARS-COV2 induced pulmonary fibrosis in moderate to severe COVID-19 patients.
So far Nintedanib has been studied extensively in various controlled clinical trials that have established its efficacy and safety. In a recently published INBUILDtm trial, Nintedanib showed significantly lower annual rate of decline in FVC (forced vital capacity) – a measure of lung health – with various progressive fibrosing interstitial lung diseases.
"With limited treatment options available, interstitial lung diseases pose a significant treatment challenge in India. The high price of newer treatments and the pill burden of existing options only add to poor patient adherence. By introducing Nindanib, we hope to substantially reduce both the pill and cost burden for patients in India,” said Alok Malik, group vice president & business head, India Formulations. He added, “Glenmark continues to invent and innovate healthcare solutions that meet specific and often hard-to-address needs of patients in India and the world.”
Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, launched Sutib, the generic version of sunitinib oral capsules to treat kidney cancer in India.
The drug is launched at a MRP that is approximately 96 per cent lower than the MRP compared to the innovator brand, priced at Rs. 7,000 (50 mg), Rs. 3,600 (25 mg) and Rs. 1,840 (12.5 mg) per month. Sunitinib is also approved by the US Food and Drug Administration (FDA).
Kidney cancer (renal cell carcinoma) is a disease of uncontrolled cell growth in the lining of small tubes in the kidney. In the past decade, advances in research and drug development have begun to shift the paradigm of this disease.
Sunitinib is an oral multi-kinase inhibitor (MKI), works by blocking several enzymes that promote cell growth. It is useful for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It is also approved for patients with certain type of pancreatic neuroendocrine tumours.
According to a Globocan 2020 report, there are close to 40,000 patients with renal cancer in India. For over a decade, sunitinib has been well recognized as one of the "gold-standard" of care in cases of fast-spreading (metastatic) renal cancer. Research shows that sunitinib alone has helped reduce the risk of progression of renal cancer by 58%.
Commenting on the launch, Alok Malik, group vice president and business head, India Formulations, said, "Oncology is an important focus area for Glenmark. We recognize that advanced kidney cancer is a complex disease and patients in India are faced with limited treatment options. Glenmark is committed to bringing targeted and effective medicines at an affordable cost to physicians and their patients."
Glenmark Pharmaceuticals has launched rufinamide tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel tablets, 200 mg and 400 mg of Eisai.
Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for rufinamide tablets USP, 200 mg and 400 mg, with a paragraph IV certification and received final approval on May 16, 2016.
Commenting on the launch, Sanjeev Krishan, president, Glenmark North America said, “We are very pleased to be one of the first generic companies in the US to offer lower cost alternative to Banzel tablets, 200 mg and 400 mg. The launch is our commitment to provide quality and affordable healthcare to our markets for patients.”
According to IQVIA sales data for the 12 month period ending April 2021, the Banzel tablets, 200 mg and 400 mg market achieved annual sales of approximately $285.3 million.
Glenmark’s current portfolio consists of 172 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA.