Biosimilar Onslaught Dents Global Blockbuster Humira

The dominance of the autoimmune disease treatment Humira (active ingredient: adalimumab), once the world's best-selling drug, is waning. Sandoz's biosimilar Hyrimoz has rapidly gained market share, pulling down Humira's share, with Samsung Bioepis' Hadlima closely following.

According to a report published by Samsung Bioepis on the 15th, Humira's adalimumab market share fell to 82% as of May, a 13% decrease compared to March. Since the patent expired in July last year, Humira has faced significant revenue decline due to the surge in biosimilars. As of last month, there are 10 Humira biosimilars available in the U.S. market alone.

In 2022, Humira generated $21.2 billion (approximately 29 trillion KRW) in sales. However, with the competition from biosimilars, last year's revenue dropped by about 32% to $14.4 billion (approximately 19 trillion KRW). This year's expected revenue for Humira is projected to be $12.4 billion (approximately 17 trillion KRW).

The biosimilar that has captured the most market share from Humira is Hyrimoz. Sandoz has partnered with Cordavis, a subsidiary of CVS Health, one of the top three insurers in the U.S., to sell Hyrimoz. Notably, in April, CVS Caremark, another CVS Health subsidiary, removed Humira from its insurance list, significantly boosting Hyrimoz's sales. Hyrimoz now holds over 10% of the adalimumab market share.

Korean companies Samsung Bioepis and Celltrion have also entered the U.S. market with Humira biosimilars. Samsung Bioepis launched Hadlima, and Celltrion launched Yuflyma, both aiming to expand their market share.

Samsung Bioepis is aggressively targeting the market with competitive pricing. Hadlima is priced approximately 86% lower than Humira and is among the lowest-priced of the 10 biosimilars. Hadlima holds about a 2% share in the adalimumab market.

Celltrion has adopted a dual pricing strategy. Initially, it launched a high-priced product with a 5% discount off Humira's wholesale price. In May, it introduced a lower-priced version of Yuflyma, with an 85% discount off the original wholesale price. The high-priced product is supplied to the public insurance market, where rebates are less prevalent, while the lower-priced product targets the private insurance market, aiming to ensure profitability across the board.