Biosimilar drugs breaking high-cost barrier to cancer immunotherapy

A biosimilar is a biological medicine made to be highly similar to an already approved original drug. Because biological medicines are complex, a biosimilar is not described as an ordinary chemical copy. It must show that it has no meaningful differences in quality, safety or clinical performance. This can make treatment more affordable after the original product’s market protection or exclusivity no longer prevents competition.

Nivolumab is a checkpoint-inhibitor immunotherapy used for many cancers. A cheaper biosimilar aims to produce the same immune effect as the original nivolumab: helping immune cells recognise and attack cancer. The article reports that patients have responded well after the cheaper version became available, while Indian research is also examining lower doses in certain settings.

The price change is substantial. A cycle that once cost over a lakh of rupees can cost about Rs 30,000. Four more nivolumab versions are expected, potentially lowering the price to Rs 10,000. However, comparability alone does not guarantee access if hospitals do not stock cheaper products.

The reported price reduction is from more than Rs 1 lakh per nivolumab cycle to roughly Rs 30,000. That is a major fall for families paying for repeated cancer treatment. The cheaper price followed the arrival of a biosimilar, and doctors reported that more patients were willing to consider the drug.

The access gap was severe before this shift. A Tata Memorial Centre study found that only 2.8% of patients eligible for immunotherapy were receiving it in 2022. The figure shows that eligibility did not translate into treatment for most patients, largely because cost made the medicine difficult to afford.

Doctors now report a substantial rise in prescriptions, although the overall increase has not yet been quantified. Dr Imran Shaikh said his nivolumab prescriptions rose by more than 50% in six months. Four additional versions could lower the price further, but availability and hospital stocking will determine how much patients actually benefit.

Cancer immunotherapy treats cancer by helping the body’s immune system recognise and destroy cancer cells. Checkpoint inhibitors are a major type. They target signals that normally restrain immune-cell activity. Blocking those signals can allow immune cells to respond more strongly against a tumour, although the effect depends on the cancer and the individual patient.

Nivolumab is a checkpoint inhibitor highlighted in the article. It is described by Tata Memorial Centre doctors as effective in 25 tumours, with about 100 indications. Its reported benefits include much longer survival for some people with melanoma and five-year survival for some patients with advanced lung cancer.

Access remains limited despite the potential. India offers seven checkpoint inhibitors, while China offers 35, according to Dr Imran Shaikh. Apart from nivolumab, the other six available in India are imported and may cost lakhs of rupees. Lower prices could expand use, but immunotherapy is not effective for every patient.

Wider access can change both survival and the type of treatment patients receive. The article gives melanoma as the clearest example: earlier, barely five in 100 patients achieved long-term survival, while survival has now increased to 50% with immunotherapy. This does not mean every patient will benefit, but it shows the potential in a responsive cancer.

Some patients with advanced lung cancer are now living five years or longer, according to Dr Kumar. In selected MSI-high colorectal cancers, early treatment with immunotherapy may avoid chemotherapy, radiotherapy and surgery. The article says such patients may keep their native organ intact when immunotherapy works.

The effect depends on cancer type, stage and individual biology. Cheaper nivolumab can make treatment possible for more people, but price alone is not enough. Doctors need evidence-based selection, appropriate dosing and reliable access. Hospitals must also stock affordable versions so the treatment reaches patients rather than remaining only theoretically available.

A lower listed price does not automatically become a lower patient bill. The article reports that some hospitals require patients to buy medicines through their own pharmacies. If those pharmacies earn more from expensive original medicines, they may have little financial reason to purchase or promote cheaper alternatives.

K M Gopakumar of Third World Network warned that hospitals might favour original medicines because of higher margins. This creates a distribution problem, not just a pricing problem. Even when a biosimilar is approved and available nationally, a patient cannot benefit if the hospital does not stock it or does not offer it as an option.

The issue could become more important as four additional nivolumab versions are expected. Their entry may reduce the price from Rs 30,000 to Rs 10,000, but savings will depend on purchasing and dispensing practices. Tata Memorial Centre says it arranges medicines so patients pay the least, though wider systems may need stronger incentives or oversight.

Immunotherapy works only when the cancer and the patient’s biology allow an effective immune response. Different tumours use different ways to resist immune attack, and patients vary in how strongly they respond. That is why Dr Kumar stresses that no medicine works for everyone, including checkpoint inhibitors.

Cancer stage and biomarkers help guide choices. The article highlights MSI-high colorectal cancer. In selected patients who come at an early stage, immunotherapy may work without chemotherapy, radiotherapy or surgery, potentially leaving the native organ intact. The result depends on the tumour’s MSI status and the clinical setting, not simply on having colorectal cancer.

Stage also matters in other cancers. Immunotherapy has improved outcomes in melanoma, while some people with advanced lung cancer now live five years or longer. These are examples, not guarantees. Doctors must match the drug to the cancer, biomarker and stage, and use evidence-based dosing rather than assuming that a cheaper treatment will suit every patient.

Patents and related market protections can initially limit competition around a new medicine, while biosimilars can create competition once they are able to enter. The article does not detail nivolumab’s patent status. In general, more approved competitors can pressure prices downward, but competition matters only when hospitals and pharmacies make those products available.

Clinical evidence determines whether a treatment is worth using and for whom. TMC research is examining lower-dose and short-course approaches, while the article also points toward evidence-based full-dose, full-course treatment as biosimilars become affordable. Biomarkers, cancer type and stage then help doctors select patients most likely to respond.

Pricing rules can reduce trade margins across medicines. India’s National Pharmaceutical Pricing Authority capped trade margins on 137 anti-cancer medicines, with projected annual savings of Rs 2,500 crore. Yet distribution can block savings if hospitals favour higher-margin originals. Effective and affordable care therefore requires evidence, competition, fair pricing and reliable stocking.