Celltrion's Remsima SC and Zimventra Poised to Join '1 Trillion Won Club' After Breaking Through U.S. Insurance Barriers

Remsima SC Product Line Achieves Sales of 456.2 Billion Won in H1

On Track to Reach 1 Trillion Won Within This Year

U.S. Insurance Reimbursement Network Cited as Key Success Factor

Achieves 90% Coverage Just Seven Months After Launch

"Existing Networks to Be Leveraged for Future Products"

Celltrion is on the verge of having its second product line with annual sales of 1 trillion won following Remsima. This milestone is due to the steady foundation built by Remsima SC in Europe, along with the rapid growth of Zimventra sales in the United States. Analysts point out that Celltrion's strategy—effectively overcoming the high insurance barriers in the U.S. and lowering the patient access barrier to high-priced pharmaceuticals—is a key factor behind this trend.

According to the industry as of August 31, the combined sales of Celltrion's subcutaneous (SC) formulation of infliximab, Remsima SC, and Zimventra (the U.S. product name) reached a total of 456.2 billion won in the first half of this year. Remsima SC, sold in Europe and Korea, recorded sales of 356.7 billion won, while Zimventra, marketed in the United States, achieved 99.5 billion won in sales. If this growth continues in the second half, the combined sales of Remsima SC and Zimventra are expected to reach 1 trillion won within this year.

Zimventra, in particular, has shown remarkable growth in the U.S. market. In the first half of this year, Zimventra's sales increased by 176.4% compared to the same period last year. This far exceeds the 20.3% growth for Remsima SC over the same period. While Europe provides a secure sales base for the Remsima SC product line, the United States—being the world's largest pharmaceutical market—has now established itself as a primary growth driver beginning with this quarter.

A view of the Celltrion headquarters in Yeonsu District, Incheon. The Asia Business Daily DB

The 'Key Factor' Determining Actual Prescription Rates

The industry credits Zimventra's successful entry into the U.S. market to the meticulously constructed U.S. insurance reimbursement network. In March 2024, Celltrion launched Zimventra in the United States and, in just seven months, secured contracts with the six public and private insurance sectors managed by the nation's three largest Pharmacy Benefit Managers (PBMs). This elevated Zimventra's reimbursement coverage in the U.S. insurance market to over 90% by October 2024, a level that has been maintained to date.

In the U.S. market, where specialty drug prices are astronomical, securing insurance reimbursement through PBMs is considered the critical factor determining the actual prescription rate of pharmaceuticals. Since patient out-of-pocket expenses vary significantly depending on insurance coverage, FDA approval and product launch alone are not enough to drive market expansion.

According to Celltrion, the wholesale acquisition cost (WAC) of Zimventra is about 3,000 dollars per vial (approximately 4.2 million won). Considering that patients typically require biweekly dosing, the out-of-pocket cost without insurance amounts to about 8.4 million won per month. A Celltrion representative stated, "Listing on the insurer's formulary through PBM contracts is a foundational step that must precede any marketing efforts," adding, "Without sufficient reimbursement coverage, obtaining prescriptions is nearly impossible."

'Zimventra Avengers' Mobilized...Proactive Use of Existing Networks

The successful establishment of a robust reimbursement network is said to be largely due to the dedicated Zimventra team. In 2023, when Celltrion began establishing a direct sales system in the U.S., the local subsidiary's workforce increased from about 50 to around 100 employees this year. Most of these hires came from global pharmaceutical companies and were assigned to different regions across the U.S., actively engaging with major PBMs from the early days of Zimventra's launch.

It is also notable that Celltrion actively leveraged both human and material networks built from selling UPLIMA (ingredient: adalimumab) and other products, which had previously entered the U.S. market. Launched in the U.S. in July 2023, UPLIMA is now listed on the public insurance formularies of two of the three largest PBMs in the country. As of May this year, UPLIMA held an approximate 8.1% market share in the U.S.

Celltrion Zimpenetra product image. Celltrion

Additionally, the product itself precisely met the demands of the medical field, aiding its market penetration. Infliximab has long been recognized for its efficacy and safety in treating inflammatory bowel diseases (IBD) such as Crohn's disease, but as it must be administered intravenously (IV), patients have had to visit medical facilities for each dose. Zimventra, developed as an SC formulation to alleviate this inconvenience, has fueled positive expansion of reimbursement coverage in the U.S., thanks to patient demand and strong product competitiveness, according to Celltrion.

Celltrion plans to leverage its already established local sales and insurance networks to ensure the successful U.S. market entry of its follow-up products. Currently, Celltrion is directly marketing subsequent products such as Stekyma, Stovoclo, and Aptozma in the United States. Whether the PBM targeting expertise gained through Zimventra can be carried over to future product launches will be a key factor in expanding Celltrion's U.S. business going forward.

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