They are betting on one of the biggest upcoming opportunities in the oncology space as regulatory chan- ges simplify development and lower-cost alternatives promise to expand patient access.
This could allow physicians to prescribe the drug earlier in the treatment pathway.
Keytruda, the world’s best-selling medicine with global sales of $31.7 billion in 2025, is expected to lose patent protection in key markets beginning 2028-29.
The drug — a PD-1 checkpoint inhibitor used across multiple cancers including lung, head and neck, melanoma, urothelial and gastrointestinal cancers — has transformed cancer treatment globally but remains out of reach for most Indian patients because of its high cost.
The stakes extend beyond a commercial opportunity.
Industry estimates suggest Keytruda treatment can cost upwards of ₹20-30 lakh over the course of therapy, limiting access for most Indian patients.
Primus Partners estimates that biosimilar competition could eventually lower prices by 50-80 per cent, potentially expanding access to one of oncology’s most effective immunotherapies.
Biocon, Zydus Lifesciences and Dr Reddy’s Laboratories have all outlined their strategies over the past financial year. Several other companies, meanwhile, including Intas Pharmaceuticals and Sun Pharma, are seen as potential contenders as the market prepares for biosimilar competition.
According to Equirus Capital, nearly seven-eight companies are currently at different stages of developing pembrolizumab biosimilars, while others are exploring licensing partnerships to enter the market.
The rush comes as manufacturers prepare for what analysts estimate is a domestic market of around ₹1,500 crore.
Unlike traditional generic medicines, however, the field is unlikely to be crowded because biosimilar development requires investments of ₹100-150 crore and specialised manufacturing capabilities. These would limit participation to companies with established biologics platforms.
“Biosimilar development requires significant investments, with development costs ranging between ₹100 and 150 crore, besides substantial manufacturing capital expenditure. As a result, only companies with long-term biosimilar strategies are expected to participate meaningfully,” said Siddharth Iyer, sector lead, healthcare and pharma, Equirus Capital.
Company commentary suggests the race has already intensified.
During its earnings call, Biocon said recent discussions with regulators have resulted in Phase-III confirmatory efficacy studies no longer being mandatory for certain biosimilars, allowing developers to rely on analytical and manufacturing data in appropriate cases.
Chief Executive Officer (CEO) Shreehas Tambe said the company believes it is “in a position of strength” after taking an early scientific approach to regulatory discussions.
Zydus Lifesciences, which has licensed a pembrolizumab biosimilar candidate, in its analyst call, said its partner is among the most advanced developers globally. Also, the company is aiming to be among the first to file once intellectual property barriers are cleared.
Dr. Reddy’s Laboratories, through its collaboration with Alvotech, said the removal of mandatory Phase-III studies significantly reduces development costs and improves the commercial case for launching the biosimilar across markets, including the US and Europe.
CEO Erez Israeli, in his analyst call, said the revised regulatory pathway, coupled with a partnership model, lowers investment requirements while improving potential returns.
Biocon, Zydus Lifesciences and Dr. Reddy’s Laboratories did not respond to emailed queries seeking additional comments on their pembrolizumab biosimilar strategies.
Globally, competition is also gathering pace. Germany-based Formycon recently became the first non-Chinese company to complete a pivotal clinical study for its pembrolizumab biosimilar candidate FYB206, placing it among the frontrunners for launch after market exclusivity expires in major markets.
Several other companies, including Samsung Bioepis, Celltrion, Amgen, Sandoz and Henlius, are also advancing development programmes.
For patients, the growing pipeline could eventually make one of oncology’s most effective immunotherapies accessible to far more people.
India records nearly 1.5 million new cancer cases every year, with a sizeable proportion of patients clinically eligible for pembrolizumab-based therapy.
However, only a small fraction receives the treatment, as the therapy can be expensive. This is limiting access largely to patients with insurance coverage or the ability to pay out of pocket.
“The impending loss of exclusivity for Keytruda is likely to be one of the most consequential events for cancer care and the biologics industry in India,” said Nilaya Varma, cofounder and group CEO, Primus Partners.
Doctors say affordability remains the biggest barrier.
Prathamesh Pai, Senior Consultant Head and Neck Surgical Oncologist, Gleneagles Hospital, Mumbai said the use of Keytruda has already been rising as it is increasingly prescribed in earlier lines of therapy and as PD-L1 biomarker testing becomes more widely available. Existing patient assistance programmes have improved affordability to some extent, but out-of-pocket costs continue to prevent many eligible patients from receiving treatment.
“The only concern has been affordability. If prices come down, more patients will definitely benefit,” Pai said. He added that in government hospitals, fewer than 1 per cent of eligible patients are currently able to afford immunotherapy. In head and neck cancers alone, India diagnoses nearly 400,000 new cases every year, and with around half expected to recur, roughly 200,000 patients could potentially become candidates for therapies such as pembrolizumab.
The experience from previous biosimilar launches suggests competition can materially expand access. Biosimilars of blockbuster biologics such as Humira, Herceptin, Avastin and Rituxan have led to significant price reductions globally, typically in the range of 20-80 per cent depending on the market, and a corresponding increase in patient uptake as healthcare systems and physicians adopted lower-cost alternatives. Industry executives expect pembrolizumab to follow a similar trajectory, although the number of competing products is likely to remain lower than in traditional generic markets because of the complexity and cost of biosimilar development.
For Indian drugmakers, the opportunity extends beyond the domestic market. With manufacturing scale, biologics expertise and lower production costs, companies are positioning themselves to supply biosimilar pembrolizumab to emerging markets as well as regulated geographies, making the race to launch as much about global exports as domestic market share.
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