Cancer cure must not be hostage to Big Pharma, Pg11

Key Highlights:

• Immunotherapy drug Keytruda, used in cancer treatment, is priced at Rs 1.5 lakh per 100mg vial, making it unaffordable for many patients.
• A network involving hospital staff is allegedly diverting used vials, refilling them, and selling them as genuine doses at discounted rates.
• Merck & Co holds the primary patent on pembrolizumab (Keytruda's generic name) until 2028 and has built a "patent thicket" to delay cheaper alternatives.
• Indian firms are developing biosimilars of Keytruda, potentially reducing costs by up to 70%.

Detailed Insights:

• The high cost of Keytruda has led to a shadow economy where patients are vulnerable to illicit activities involving fake or diluted drugs.
• Patent thickets are strategies used by pharmaceutical companies to extend their monopoly by obtaining patents on minor modifications or related aspects of a drug.
• Indian patent laws have historically been used to prevent evergreening, which is the practice of extending patent protection on a drug through incremental changes.
• Biosimilars are complex drugs derived from living cells, requiring advanced manufacturing and facing stricter regulatory scrutiny compared to conventional generics.
• India needs to strengthen regulatory oversight, fast-track biosimilars, and invest in R&D to become a center for drug innovation and affordable therapies.
• India's success with CAR-T therapy demonstrates the potential for homegrown therapies to lower costs and expand access to cancer treatment.
• Scaling up the CAR-T model requires sustained investment in R&D, academia-industry collaboration, faster regulation, and biotech financing.

Key Concepts Involved:

• Immunotherapy: Treatment that uses the body's own immune system to fight diseases like cancer.
• Biosimilars: Biological products that are similar to already approved biological drugs.
• Patent Thicket: A strategy of obtaining overlapping patents to make it difficult for competitors to enter the market.