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K-Bio Targets the U.S. Market: Celltrion and Samsung Bioepis Close in on Originator Drugs

HealthK-Bio Targets the U.S. Market: Celltrion and Samsung Bioepis Close in on Originator Drugs
 Celltrion\'s new drug Zymfentra, an infliximab-based subcutaneous injection (SC) formulation (Provided by Celltrion) / News1
 Celltrion’s new drug Zymfentra, an infliximab-based subcutaneous injection (SC) formulation (Provided by Celltrion) / News1

Celltrion and Samsung Bioepis, South Korea’s leading biotech firms, are strengthening their foothold in the U.S., the world’s largest pharmaceutical market, by expanding their prescription sales. They have demonstrated robust growth in the markets for their flagship products, infliximab and adalimumab. Newly launched products are also gaining a stable presence in the market.

Celltrion’s Zymfentra rebounds as infliximab and rituximab maintain dominance

According to a recent report on Biosimilar Prescription Performance in December published by Daol Investment & Securities, domestically produced biosimilars showed overall strong prescription performance in the U.S. market last month.

Celltrion is achieving steady growth with its existing core products while successfully penetrating the new drug market. In the infliximab market, Celltrion’s autoimmune disease treatment, Inflectra, has maintained its strong leadership position.

In December, Inflectra’s prescription volume reached 247,600 units, representing a 19.1% increase year-over-year and a 15.3% rise from the previous month. Its market share stands at 29.5%, closing in on the original drug Remicade, which holds 49.8%.

Celltrion’s next-generation growth driver, the subcutaneous (SC) formulation of infliximab, Zymfentra, has shown signs of recovery in prescription trends.

After a temporary adjustment in November, Zymfentra has maintained growing prescription demand across medical institutions and retail channels in December. Prescription amounts from medical institutions have been increasing, indicating that Celltrion is steadily building a stable prescription base in the U.S. market.

In the oncology drug market, Celltrion’s Truxima recorded a prescription volume of 1,804,600 units, maintaining a high market share of 31.6%. This represents an 11.6% growth rate compared to the same period last year. The bevacizumab biosimilar Vegzelma also continues to expand its prescriptions, achieving a 9.4% market share.

The ustekinumab biosimilar Yuflyma recorded 151,900 units in prescriptions, capturing a 6.5% market share. It ranks second behind Biocon’s Yesintek, which holds 15.7%, as it establishes a stable prescription base.

 Samsung Bioepis\' Hadlima (active ingredient: adalimumab) pen-type product (Provided by Organon Korea) / News1
 Samsung Bioepis’ Hadlima (active ingredient: adalimumab) pen-type product (Provided by Organon Korea) / News1

Samsung Bioepis Solidifies its Lead in the Fiercely Competitive Humira Biosimilar Market

Samsung Bioepis’s Humira recorded prescriptions of 34,600 units in December, marking a 51.8% growth compared to the same period last year and a 24.6% increase from the previous month. Its market share stands at 11.4%.

Hadlima outperformed competitors like Sandoz’s Hyrimoz, which holds 9.3%, and Boehringer Ingelheim’s Cyltezo at 4.3%, achieving the highest market share among biosimilars and proving its market leadership.

In the infliximab market, Renflexis has maintained stable performance, with prescriptions reaching 86,900 units, a 6.7% increase compared to the same period last year. It holds a 10.4% market share, competing closely with Amgen’s Avsola, which has a 10.3% share for the third position.

In the trastuzumab market, Ontruzant recorded 75,200 units, showing 26.0% growth from the previous month. The ustekinumab biosimilar Pyzchiva saw 34,900 units prescribed, demonstrating a significant growth rate of 51.7% compared to the previous month.

An industry insider noted that December showed robust overall prescription trends due to seasonal factors. It’s encouraging that our companies continue to erode the market share of original drugs, firmly establishing themselves as key players in the market.

Daol Investment & Securities analyst Lee Jisoo commented that overall, it observed solid prescription performance, with key biosimilar products maintaining a stable prescription flow.

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