Global pharmaceutical companies are rapidly changing cancer treatment injections. The advent of subcutaneous (SC) formulations, which dramatically reduce administration time compared to conventional intravenous (IV) injections, brings us closer to an era where patients can self-administer cancer medication.
Bristol-Myers Squibb (BMS) of the United States received approval from the U.S. Food and Drug Administration (FDA) last week for its subcutaneous (SC) formulation of the cancer drug Opdivo (ingredient name nivolumab), named 'Opdivo Qvantig.' It demonstrated similar efficacy and safety when compared to the traditional intravenous (IV) formulation.
The strength of the subcutaneous injection formulation is its short administration time. While it takes about 30 minutes to 1 hour to administer an immune anticancer drug through a vein (intravenously), it can be significantly reduced to about 3 to 5 minutes with the subcutaneous formulation. The pharmaceutical industry anticipates that the emergence of the subcutaneous formulation will lead to a self-administration era for cancer treatment, allowing patients to receive treatment at home.
Yoon Na-ri, head of the clinical development strategy division at GI Innovation, said, 'The ultimate goal of developing the SC formulation is to open an era where cancer patients can self-administer cancer drugs at home, not just in hospitals.' She noted, 'Securing safety is extremely important for this.'
Opdivo is a blockbuster immune anticancer drug that was first approved in 2014 for the treatment of skin cancer melanoma and has since expanded its indications to over 20 types of cancer. The annual sales figure for Opdivo in 2023 is expected to reach $10 billion (about 14.718 trillion won). The newly approved Opdivo Qvantig can be administered to patients with 11 types of cancer, including melanoma, non-small cell lung cancer, colorectal cancer, and gastric cancer.
Global pharmaceutical companies are adopting formulation changes as a key strategy to defend patents for blockbuster medications. BMS began developing the SC formulation ahead of the expiration of the main substance patent for Opdivo in 2027. The industry predicts that extending the patent with the modified formulation could prolong the period during which market share can be maintained by about 5 to 6 years.
Earlier, the Swiss pharmaceutical company Roche was the first among immune anticancer drugs to receive subcutaneous approval in Europe last year, followed by the United States in September this year. Janssen, a subsidiary of Johnson & Johnson (J&J) in the U.S., has developed the lung cancer treatment drug libervanent in SC formulation.
U.S. pharmaceutical company Merck (MSD) is also developing the SC formulation of the immune anticancer drug 'Keytruda' using domestic Alteogen technology. Japan's Daiichi Sankyo, which is ranked first in antibody-drug conjugates (ADC), is also developing the SC formulation of 'Enhertu' using Alteogen technology.