Monoclonal Antibodies

The Delhi High Court has recently cleared the way for Zydus Lifesciences to manufacture and sell a biosimilar version of Nivolumab, a blockbuster cancer drug patented by US pharmaceutical major Bristol Myers Squibb (BMS). The ruling gives a major boost to the Indian drugmaker just months before the patent’s expiry in May.

BMS currently holds the patent for Nivolumab in India, and the court’s decision allows Zydus to prepare for market entry ahead of the patent cliff.

About Nivolumab

Nivolumab is a monoclonal antibody-based immunotherapy drug used in the treatment of multiple cancers. It works by strengthening the body’s immune response against cancerous cells.

To fight infections and abnormal cells, the human body naturally produces antibodies, which are proteins that bind to specific antigens on foreign or harmful cells. Nivolumab is a lab-produced monoclonal antibody designed to mimic and enhance this natural immune function.

How Monoclonal Antibodies Work

• Monoclonal antibodies (mAbs) are produced from a single clone of a B cell, a type of white blood cell.
• They are highly specific and designed for targeted cellular action, unlike chemotherapy, which affects both cancerous and healthy cells.
• This targeted approach forms the basis of immunotherapy, a treatment modality that improves cancer control while reducing collateral damage to healthy tissues.

Unlike polyclonal antibodies, which arise from multiple cell clones and can target different antigens, monoclonal antibodies focus on a single, well-defined target.

Clinical Significance

Nivolumab is often compared with Pembrolizumab (Keytruda), another immunotherapy monoclonal antibody marketed by Merck, which remains under patent protection in India.