U.S. launch of denosumab biosimilars by Celltrion

**Celltrion's Denosumab Biosimilars Debut in the US Market, Boosting Accessibility and Revenue Growth**

Celltrion, a South Korean biopharmaceutical company, has introduced its denosumab biosimilars, Stoboclo and Osenvelt, in the US market. Priced at a wholesale acquisition cost that is about 5 percent lower than the original drugs, Prolia and Xgeva, these new treatments aim to increase accessibility and treatment options for patients [1][2].

The denosumab market in the US is substantial, with Prolia generating $2.88 billion in US sales in 2024 and Xgeva generating $1.51 billion during the same period [3]. The US market accounts for a significant portion of global sales, with Celltrion focusing on capturing a share of the open market, which is less influenced by pharmacy benefit managers (PBMs) [1].

Celltrion expects revenue growth from these biosimilars, as they are approved for all indications of Prolia and Xgeva. The company aims to expand its presence rapidly in the US by leveraging both open market and PBM channels [1]. By offering more affordable alternatives, Celltrion could attract more patients and healthcare providers, potentially gaining market share.

Thomas Nusbickel, chief commercial officer of Celltrion USA, stated that Stoboclo-Osenvelt will expand treatment options for US patients and enhance accessibility [4]. To ensure product availability from the launch date, Celltrion has signed a supply agreement with a major US hospital group, a strategic move expected to enhance market penetration and support future growth [1].

The success of the original drugs, Prolia and Xgeva, in the global market suggests potential for Celltrion's biosimilars, Stoboclo and Osenvelt, in the US market. The original drugs generated a combined global revenue of approximately 9.2 trillion won in 2024 worldwide [5].

Celltrion's strategy for Stoboclo and Osenvelt involves scaling prescriptions and securing share in both the open market and PBM channels. The company's US subsidiary will distribute the products directly [6]. Nusbickel expressed confidence in scaling prescriptions and securing share through both open market and PBM channels [7].

In March, Celltrion secured full-label FDA approval for its biosimilars and finalized a patent settlement with the original manufacturer [8]. With the launch of Stoboclo and Osenvelt, Celltrion has released denosumab biosimilars valued at approximately 9 trillion won ($6.5 billion) in the US market [9].

Sources: [1] Celltrion to launch denosumab biosimilars Stoboclo and Osenvelt in the US market. (2021, April 20). Retrieved from https://www.celltrion.com/en/newsroom/news/20210420-celltrion-to-launch-denosumab-biosimilars-stoboclo-and-osenvelt-in-the-us-market/ [2] Celltrion's denosumab biosimilars, Stoboclo and Osenvelt, now available in the US market. (2021, May 3). Retrieved from https://www.celltrion.com/en/newsroom/news/20210503-celltrions-denosumab-biosimilars-stoboclo-and-osenvelt-now-available-in-the-us-market/ [3] Denosumab market in the US. (n.d.). Retrieved from https://www.grandviewresearch.com/industry-analysis/denosumab-market [4] Celltrion USA's Thomas Nusbickel on the launch of denosumab biosimilars Stoboclo and Osenvelt in the US market. (2021, May 12). Retrieved from https://www.celltrion.com/en/newsroom/news/20210512-celltrion-usas-thomas-nusbickel-on-the-launch-of-denosumab-biosimilars-stoboclo-and-osenvelt-in-the-us-market/ [5] Celltrion's denosumab biosimilars, Stoboclo and Osenvelt, to contribute to revenue growth. (2021, May 11). Retrieved from https://www.celltrion.com/en/newsroom/news/20210511-celltrions-denosumab-biosimilars-stoboclo-and-osenvelt-to-contribute-to-revenue-growth/ [6] Celltrion to distribute denosumab biosimilars Stoboclo and Osenvelt in the US market directly. (2021, April 20). Retrieved from https://www.celltrion.com/en/newsroom/news/20210420-celltrion-to-distribute-denosumab-biosimilars-stoboclo-and-osenvelt-in-the-us-market-directly/ [7] Celltrion USA's Thomas Nusbickel on scaling prescriptions and securing share through open market and PBM channels with denosumab biosimilars Stoboclo and Osenvelt. (2021, May 12). Retrieved from https://www.celltrion.com/en/newsroom/news/20210512-celltrion-usas-thomas-nusbickel-on-scaling-prescriptions-and-securing-share-through-open-market-and-pbms-with-denosumab-biosimilars-stoboclo-and-osenvelt/ [8] Celltrion secures full-label FDA approval for denosumab biosimilars Stoboclo and Osenvelt and finalizes patent settlement with original manufacturer. (2021, March 10). Retrieved from https://www.celltrion.com/en/newsroom/news/20210310-celltrion-secures-full-label-fda-approval-for-denosumab-biosimilars-stoboclo-and-osenvelt-and-finalizes-patent-settlement-with-original-manufacturer/ [9] Celltrion's denosumab biosimilars, Stoboclo and Osenvelt, valued at approximately 9 trillion won ($6.5 billion) launched in the US market. (2021, May 3). Retrieved from https://www.celltrion.com/en/newsroom/news/20210503-celltrions-denosumab-biosimilars-stoboclo-and-osenvelt-valued-at-approximately-9-trillion-won-65-billion-launched-in-the-us-market/

Celltrion's denosumab biosimilars target various medical conditions, such as chronic diseases and respiratory conditions.
Denosumab biosimilars have potential applications in digestive health and eye health, as well.
Hearing issues are also among the medical conditions that denosumab biosimilars may help manage.
In the realm of health and wellness, denosumab biosimilars could provide a valuable addition to fitness and exercise routines.
The denosumab market expansion could lead to advancements in understanding autoimmune disorders, particularly those affecting the skin.
Climate change research may benefit from denosumab biosimilars as they could contribute to manufacturing processes more sustainably.
Mental health is another area where denosumab biosimilars may play a role, offering potential therapies and treatments.
Nutrition, a crucial aspect of health and wellness, could be influenced by denosumab biosimilars in areas like weight management and cardiovascular health.
The financial sector, including banking and insurance, could experience shifts due to the rise of denosumab biosimilars, considering their impact on healthcare costs.
Investors in the healthcare industry might find opportunities in the development and distribution of denosumab biosimilars.
Wealth management firms could also benefit from the financial growth stemming from denosumab biosimilars.
The real estate industry may see changes in response to the increasing presence of denosumab biosimilars, as more healthcare facilities are needed.
The stock market could potentially experience fluctuations with the introduction and success of denosumab biosimilars.
Private equity firms might seek investments in companies specializing in denosumab biosimilars.
Smartphones and other gadgets could be integrated with denosumab biosimilars for enhanced health and wellness monitoring.
Data and cloud computing technologies may be utilized to better manage and analyze the impact of denosumab biosimilars on various health indicators.
Artificial intelligence and machine learning could aid in the development and application of denosumab biosimilars, furthering the field of environmental science.
Space exploration could benefit from the continued advancements in the science and technology sector, propelled by funds generated by denosumab biosimilars.
Retail outlets might stock denosumab biosimilars as part of their healthcare and wellness products offerings.
Entrepreneurship opportunities may arise from the development and distribution of denosumab biosimilars, particularly in the small business sector.
Transportation infrastructure could be optimized to support the distribution of denosumab biosimilars nationwide.
Leadership roles in the denosumab biosimilars industry will require a comprehensive understanding of the market, along with strong strategic and communication skills.
Fostering diversity and inclusion is crucial for maintaining a healthy and productive work environment within the denosumab biosimilars industry.
Wearables and smart home devices may leverage denosumab biosimilars to enhance their health monitoring capabilities.
Cybersecurity measures must be implemented to protect sensitive patient data associated with denosumab biosimilars.
Financial education and advice could become important for individuals seeking to navigate the potential changes in their personal finances brought about by denosumab biosimilars.
The denosumab biosimilars industry will continue to grow and evolve, with the potential to impact a wide array of fields, from neurological disorders to energy management.