Celltrion Receives US Approval for Two Denosumab Biosimilars... Targeting $9 Trillion Market

Approval Obtained in the U.S. Following Korea and Europe

Celltrion announced on the 4th that its biosimilar of the bone disease treatment drug 'Prolia-Xgeva (active ingredient denosumab)', 'STOBOCLO-OSENVELT', has received approval from the U.S. Food and Drug Administration (FDA).

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Celltrion confirmed efficacy equivalence and pharmacodynamic similarity compared to the original drugs through a global Phase 3 clinical trial involving 479 osteoporosis patients worldwide, and applied for approval of both STOBOCLO and OSENVELT in the United States.

With this approval, STOBOCLO has been authorized for all indications held by the original drug in the U.S. for postmenopausal osteoporosis, and OSENVELT for skeletal-related complications in cancer patients with bone metastases and giant cell tumor of bone, respectively.

The original products of STOBOCLO and OSENVELT, Prolia and Xgeva, recorded combined global annual sales of approximately $6.599 billion (about 9.2 trillion KRW) last year. Of this, sales in the U.S. alone accounted for about $4.392 billion (about 6.15 trillion KRW), representing 67% of global sales. Having completed patent agreements with the original drug developers, Celltrion plans to launch both products in the U.S., the world's largest pharmaceutical market, as early as this year.

Notably, Celltrion secured the 'First Mover' status by being the first to obtain approval for related competing products in Korea last November. Having recently gained additional approvals in Europe (EC) last month and the U.S. this month, the company plans to promptly introduce the products to major global markets to accelerate sales growth.

Celltrion has been making significant strides in expanding its treatment portfolio by consecutively obtaining approvals for new indications such as ophthalmic diseases and bone diseases, following autoimmune disease treatments and anticancer drugs in major global markets.

Just this year, Celltrion has obtained three approvals in the U.S., including Aptosma, and four product approvals last month in Europe, including Idengel, STOBOCLO, OSENVELT, and Aptosma, totaling seven approvals in the two major global markets. The company's previously stated goal of building an 11-product portfolio by 2025 was already achieved early last year in Korea, and the 11-product lineup was completed in Europe last month as well.

A Celltrion official stated, "We are reaffirming our in-house product development capabilities by consecutively obtaining biosimilar approvals in major global countries. We will diligently complete the remaining pipeline approval processes and ensure that the approved products quickly penetrate the market to drive sales growth."

Meanwhile, Celltrion reported record-breaking sales last year by achieving its sales target of 3.5 trillion KRW. This year, the company aims to reach annual sales of 5 trillion KRW and plans to secure a total of 22 products by 2030, targeting annual sales of 12 trillion KRW.

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