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Truxima: How the First Korean Biosimilar Achieved 35.8% Market Share in the U.S.!

HealthTruxima: How the First Korean Biosimilar Achieved 35.8% Market Share in the U.S.!
Truxima / Provided by Celltrion
Truxima / Provided by Celltrion

Celltrion’s blood cancer treatment, Truxima (rituximab), has become the first South Korean biosimilar to secure the top spot in prescription market share in the U.S. This milestone comes as the Donald Trump administration’s recent decision to exempt biosimilars from tariffs boosts expectations for Celltrion’s performance targets this year.

According to IQVIA, a leading pharmaceutical market research firm, Truxima captured a 35.8% market share by prescription volume in February, clinching the number one position. This remarkable achievement comes just over six years after its U.S. market entry in November 2019.

Truxima’s success is translating into substantial revenue. The drug generated over 300 billion KRW (about 203 million USD) in North America last year, including the U.S. market, marking a robust 40% year-over-year growth. It has solidified its position as a key revenue driver for Celltrion.

This accomplishment is particularly significant given the recent U.S. pharmaceutical tariff policy announcements, which suggest even greater potential for Celltrion’s market expansion.

The U.S. government’s decision to exclude biosimilars from tariff applications benefits the majority of Celltrion’s U.S. sales. Moreover, Zymfentra, currently marketed as a new drug in the U.S., will be manufactured at the Branchburg facility, effectively sidestepping any tariff impacts.

In related news, Celltrion’s flagship autoimmune disease treatment, Inflectra (infliximab), has secured a 30.5% market share, leading prescription volumes among biosimilar products in the U.S.

Celebrating its 10th anniversary in the U.S. market this year since its November 2016 launch, Inflectra has consistently maintained over 30% market share annually, cementing its status as a global blockbuster drug.

Additionally, Zymfentra’s prescription volume this January surged more than threefold compared to last year, indicating strong growth momentum and potentially accelerating prescription synergies between the two products.

Celltrion’s newly launched high-revenue product line is also gaining traction, with increasing market share and expanded reimbursement coverage.

STEQEYMA (ustekinumab), an autoimmune disease treatment launched last March, has quickly risen to the forefront of biosimilar prescriptions, capturing a 10.2% market share.

Industry analysts attribute this growth to STEQEYMA’s preferred drug status in formularies of the top three U.S. pharmacy benefit managers (PBMs) and among the top five large PBM public and private insurance prescription lists, securing over 50% reimbursement coverage.

A Celltrion spokesperson stated that Truxima’s achievement of the top prescription market share in the world’s largest pharmaceutical market, outperforming both original drugs and competitors, will further enhance its recognition and preference. With both the established and new products showing remarkable performance globally, including in the U.S., we are confident in meeting the company’s financial targets for this year.

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