Major anti-breast cancer drug off patent: Government in Parliament; room for cheaper generics

New Delhi, March 28

The government on Tuesday informed Parliament that a major anti-breast cancer drug, Palbociclib, had gone off patent, creating opportunities for production of generic versions.

While the branded Palbociclib drug version cost over Rs 80,000 a month, the generic formulations now available have cut the drug cost by over 90 pc to around Rs 3800 a month.

The generic versions are currently either being produced or are in the process of being manufactured by around 15 pharmaceutical companies in India, health ministry sources said.

This was made possible after Pfizer’s Indian patent on Palbociclib expired on January 10 this year.

The Minister of State for Health in her answer on breast cancer drug availability, informed the Rajya Sabha today that as per the ICMR-National Cancer Registry Programme data, the estimated number of incidenceof breast cancer in the country for the year 2022 is 216108.

“As per Central Drugs Standard Control Organisation (CDSCO, palbociclib has gone offpatent on January 10, 2023.As informed by Department of Pharmaceuticals, National Pharmaceutical Pricing Authority vide dated February 27, 2019, has put a cap on Trade Margin of 42 selected nonscheduled anti-cancer medicines on pilot basis under ‘Trade Margin Rationalization’ approach. Anti-breast cancer drug Ribociclib was also included in this,” Pawar said.

Importantly nearly half the breast cancer patients detected annually out of around 14 lakh overall cancer patients, half (nearly 1.2 lakh) require Palbociclib, which is prescribed in combination with hormonal treatments.

Palbociclib is normally prescribed for 18 months with the generic drug version costing around Rs 3800 a month instead of Rs 80,000 previously.

Sun Pharmaceuticals was the first to launch a generic version of Pfizer’s palbociclib in India on January 11.