Novartis, Eli Lilly Oppose Kerala High Court Petition to Cut Ribociclib and Abemaciclib Prices
核心洞察
Novartis and Eli Lilly have filed counter-affidavits opposing a Kerala High Court (搜索) petition seeking government intervention to lower prices of ribociclib and abemaciclib.
Court data show ribociclib earned $12.7 billion globally from 2020 to 2025 versus $55.7 million in India, about 0.4% of global revenue.
Abemaciclib generated $19.6 billion globally in the same period against $31.5 million in India, roughly 0.16% of global sales.
Novartis and Eli Lilly are contesting a petition before the Kerala High Court (搜索) that seeks government intervention to mandate price reductions for two patented breast cancer (搜索) medicines, Novartis's ribociclib and Eli Lilly's abemaciclib. In counter-affidavits, the two companies argued that they incurred substantial costs in developing the drugs, but did not provide the court with specific figures for those expenses, according to a report by ToI's Rema Nagarajan.
India Sales a Fraction of Global Revenue
Data placed before the court shows a wide gap between the global commercial performance of both drugs and their Indian footprint. Novartis made about $12.7 billion from global sales of ribociclib between 2020 and 2025, while sales in India during the period stood at $55.7 million, or about 0.4% of global revenue. Lilly's abemaciclib generated $19.6 billion globally over the same period, compared with $31.5 million in India, or about 0.16% of global sales.
The India sales figures were sourced from market research firm IPSOS, while the global revenue figures were based on disclosures by the drugmakers.
Development Costs Under Scrutiny
The case has brought the cost of developing the two drugs into focus, with respondents presenting estimates suggesting that clinical-trial expenditure was substantially below the global revenues generated by the medicines. An affidavit filed by Jamie Love, executive director of US-based Knowledge Ecology International (搜索), estimated that Novartis spent $494.5 million on clinical trials for ribociclib, while Lilly spent more than $469 million on trials for abemaciclib.
A separate calculation submitted by two respondents, including advocate Majida MA, who is undergoing treatment for breast cancer (搜索), put the estimated clinical-trial costs higher at about $667.5 million for ribociclib and more than $633 million for abemaciclib. That calculation used a more recent estimate of the cost per clinical-trial participant from a 2024 paper published in JAMA Network Open.
The court was also presented with the Tufts Center for the Study of Drug Development (搜索) estimate that bringing a prescription drug to market costs about $2.6 billion. The centre receives substantial funding from the pharmaceutical industry and bases its estimates on data supplied by drug companies. The figure has faced criticism over claims that it may overstate development costs and support pharmaceutical companies' justification for high prices. Even using the $2.6 billion estimate as a broad benchmark, the sales figures cited in the case indicate that global revenues from both drugs have exceeded that amount by several multiples.
Manufacturing Cost Estimates and the Price Gap
The petition has also brought the manufacturing cost of ribociclib into focus. Yale University (搜索) drug-costing expert Dr Melissa Barber estimated the cost of producing a 200 mg ribociclib tablet at about $0.85 (Rs 81) when the active pharmaceutical ingredient is manufactured in-house, and roughly $1.29 (Rs 123) when the API is imported.
The prescribed regimen involves three tablets a day for 21 days. Based on the manufacturing-cost estimates, the monthly cost would work out to roughly Rs 5,100 to Rs 7,750, compared with Rs 78,400 charged by Novartis in India, according to the data presented before the court.
Generic Precedents Cited
The case has cited India's generic-drug industry as an example of how patent-protected medicines can see steep price reductions once generic production begins. Bayer's patented kidney and liver cancer drug Nexavar was priced at about $5,500 a month, while Natco's generic version cost around $175. Similarly, the hepatitis C (搜索) treatment combination of sofosbuvir and daclatasvir, which cost almost $150,000 in the US, became available for about $200 to $350 after generic production in India.
Regulatory Framework
India's National Pharmaceutical Pricing Authority (搜索) regulates drug costs under the Drug Price Control Order. The petition seeks government intervention to improve access to the two breast cancer (搜索) treatments, and the Kerala High Court (搜索) is considering it against the backdrop of the wide gap between the prices of patented medicines and the costs cited for their manufacture.