Among Patent-Expired Drugs, '3rd in Imports' Gardasil... When Will HPV Prevention and Treatment Vaccine Be Localized?

Gardasil 4 Patent Expired in 2014
No Domestic Generic Drugs Yet
SK Bioscience and Others Developing... Commercialization Will Take Time

MSD's Gardasil 4. The patent for Gardasil 4, well known as a cervical cancer vaccine, expired in 2014.
[Photo by MSD Korea]

[Asia Economy Reporter Lee Gwan-ju] The dominance of Gardasil, the human papillomavirus (HPV) preventive vaccine by the US global pharmaceutical company MSD, well known for its cervical cancer vaccine, continues. Despite the expiration of the patent for Gardasil 4-valent, no domestic follow-up drugs have yet been released. Although domestic pharmaceutical and bio companies have ventured into developing HPV preventive and therapeutic vaccines, it is expected to take considerable time before they can practically replace foreign vaccines.

‘De facto Monopoly’ Gardasil’s Price Soars in Two Years

According to the pharmaceutical and bio industry on the 1st, the patent for Gardasil 4-valent expired back in 2014. Since then, the global pharmaceutical company GlaxoSmithKline (GSK) launched an equivalent drug called Cervarix, but domestic production has not been achieved. According to the list of drugs with expired registered patents released yesterday by the Ministry of Food and Drug Safety, Gardasil ranked third among imported drugs with expired patents, following Roche’s anticancer drug Herceptin and Kyowa Kirin’s neutropenia treatment Neulasta. Both Herceptin and Neulasta have domestically developed biosimilars and biobetters, making Gardasil the only imported drug with high import volume that lacks a domestic substitute. Imports of Gardasil steadily increased from $11 million (KRW 15.6 billion) in 2019 to $12 million (KRW 17 billion) in 2020, and $12.45 million (KRW 17.6 billion) last year.

Gardasil’s market share in the domestic HPV preventive vaccine market is known to exceed 70%. Along with this dominance, prices have also risen. MSD raised the supply price of the Gardasil 9-valent vaccine by 15% last April and again by 8.5% this July, bringing the current domestic supply price close to KRW 150,000. In practice, vaccination at hospitals or clinics costs about KRW 600,000 for three doses, which is a significant burden. The Korea Bio Association’s Bioeconomy Research Center pointed out regarding the price increase, “Drug prices are important matters related to accessibility and public health,” adding, “Reasonable pricing should be established in the pharmaceutical market, and if there are acts restricting competition, they should be monitored and improved.”

Domestic Production of HPV Preventive and Therapeutic Vaccines Expected to Take Time

Ultimately, there is consensus that domestic products must be developed to lower the price of HPV preventive vaccines. However, it is inevitable that commercialization will take time. SK Bioscience was the most advanced in developing an HPV preventive vaccine. In 2020, it completed Phase 2 clinical trials for the vaccine candidate ‘NBP-615,’ confirming safety and immunogenicity. However, due to the COVID-19 pandemic, entering Phase 3 trials is expected to take some time. A SK Bioscience official explained, “We are focusing on COVID-19 vaccine development and post-COVID response,” adding, “We will continue development with the HPV preventive vaccine in our pipeline.” IGEN also completed Phase 1 clinical trials for its HPV preventive vaccine ‘EG-HPV’ in 2014, but has not reported follow-up clinical trials as it has concentrated on other pipelines such as COVID-19 vaccine development.

However, development of HPV therapeutic vaccines is relatively active. Genexine’s DNA vaccine for cervical cancer treatment, ‘GX-188E,’ recently completed Phase 2 clinical trials in combination with the immuno-oncology drug Keytruda successfully. In the clinical trial involving 60 patients, an objective response rate (ORR) of 31.7% was observed, with 10% achieving complete remission and 21.7% partial remission. The median overall survival was 17.2 months, indicating potential for treatment efficacy and survival extension. Cellid also announced results of Phase 2a clinical trials for the cervical cancer immunotherapy vaccine ‘BVAC-C’ at the American Society of Clinical Oncology (ASCO) last year, reporting an ORR of 27%. It is currently preparing for Phase 2b trials.

An industry insider said, “For HPV preventive vaccine price reduction, domestic production must be achieved, but the development process is difficult, and global clinical trials require enormous costs and time, which is a heavy burden for developing companies,” adding, “If domestic development remains sluggish despite patent expiration, institutional support measures to promote domestic self-reliance should be considered.”

This content was produced with the assistance of AI translation services.