Dr. Reddy’s Laboratories has launched Toripalimab, a New Biological Entity (NBE) in the domestic market.
“The launch of Toripalimab is a significant milestone for patients diagnosed with nasopharyngeal carcinoma (NPC) in India. NPC is a rare form of head and neck cancer. However, the prognosis of the disease for patients in advanced stages is poor, and India is among the top five countries in the world in terms of disease burden,’‘ M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s said in a release.
It is the `only immuno-oncology drug approved by various regulatory authorities around the world such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
In 2023, Dr. Reddy’s entered into a licence and commercialisation agreement with Shanghai Junshi Biosciences Co. Ltd for Toripalimab.
Under this agreement, Hyderabad-based Dr. Reddy’s obtained exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and various countries in Latin America. Additionally, the agreement allows Dr. Reddy’s to expand the scope of the license to cover Australia, New Zealand and nine other countries.
With this launch by Dr. Reddy’s, India becomes the third country in the world after China and the United States to receive access to this next generation PD-1 inhibitor1. Dr. Reddy’s will market it under the brand name Zytorvi in India. The standard of care for RM-NPC in India before Toripalimab was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin.
As the next generation PD-1 inhibitor, Toripalimab has demonstrated superior outcomes for RM-NPC versus standard of care, thereby meeting a significant unmet need for patients with NPC in India. This launch is also a major milestone for us as a company.
Dr Reddy’s portfolio of standard of care small molecules and biosimilars across cancer types in India and other emerging markets has included Reditux, Versavo, Lenangio, and Hervycta.
NPC is a malignant tumour that arises from the epithelium of the nasopharynx. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. In India, there were 6,519 newly diagnosed cases of NPC in 20224.
The highest age-adjusted rates for NPC were found in the northeastern states in India, with Kohima in Nagaland having an incidence of 19.4/100,000 population.