Blockbuster drug, proven against a range of cancers, may get much cheaper, Pg17

Key Highlights:

• The Delhi High Court allowed Zydus Lifesciences to manufacture a cheaper biosimilar of Nivolumab, a cancer therapy drug, considering public interest.
• Bristol Myers-Squibb (BMS) holds the patent for Nivolumab in India, expiring in May 2026.
• Nivolumab, marketed as Opdivo globally and Opdyta in India, generated approximately $9 billion in revenue for BMS in 2023.
• A year's treatment of Zydus's biosimilar Tishita is projected to cost between Rs 3.86 to 6.46 lakh.

Detailed Insights:

• Nivolumab is an immunotherapy drug effective against various cancers, offering improved duration and quality of life, especially in lung cancers.
• The drug enhances the immune response to fight cancerous cells, differing from chemotherapy by targeting only cancerous cells.
• The Prime Minister Jan Arogya Yojana (PMJAY) does not cover immunotherapies, making drugs like Opdyta unaffordable for many Indian patients.
• The US Food and Drug Administration (FDA) has designated Nivolumab as a "Breakthrough Therapy", expediting its development and rollout.
• The Delhi High Court's decision considered that Zydus's biosimilar drug would be 70% cheaper and the patent's impending expiry in about four months.

Key Concepts Involved:

• Biosimilar: A biological product that is similar to another already approved biological product.
• Monoclonal antibody: Lab-produced antibody molecules used for targeted cellular action to enhance or mimic the immune system.
• Immunotherapy: A type of cancer treatment that helps the immune system fight cancer.