28 Trillion Won Autoimmune Treatment 'Stelara' Market... 'K-Similar' Challenges

Published 24 Oct.2024 07:00(KST)

As the domestic pharmaceutical and bio industry performs well in the global biosimilar market, they are challenging the autoimmune disease treatment Stelara, whose patent expiration is imminent. The Stelara market, with a global size exceeding $20 billion (approximately 28 trillion KRW), has attracted not only existing biosimilar companies such as Celltrion and Samsung Bioepis but also the traditional pharmaceutical company Dong-A ST.

Johnson & Johnson (J&J) Innovative Medicine's autoimmune disease treatment 'Stelara'

Stelara is an autoimmune disease treatment developed by Johnson & Johnson (J&J) Innovative Medicine (formerly Janssen). It treats various inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The active ingredient of Stelara, ustekinumab, had a global market size of $20.323 billion last year, and Stelara itself is a blockbuster drug with sales of $10.858 billion (approximately 15 trillion KRW), accounting for more than half of this market.

With the expiration of Stelara's U.S. substance patent in September last year, competition for biosimilar launches has heated up worldwide. Various biosimilars have already been launched in Europe, and biosimilars will be introduced in the U.S. starting next year. Consequently, Stelara's sales have entered a downward trend. Stelara's sales in the third quarter of this year were $2.7 billion (approximately 3.7 trillion KRW), a 7% decrease compared to the same period last year.

Samsung Bioepis's biosimilar for autoimmune disease treatment, 'Fizchiva'

Currently, five products have challenged the Stelara biosimilar market in the U.S. In Korea, Samsung Bioepis (Pizciba) and Dong-A ST (Imuldosa) have received approval from the U.S. Food and Drug Administration (FDA). Celltrion (Stekima) also applied for FDA approval in June last year and is awaiting results. Overseas, Amgen (Wezlana) in the U.S., Alvotech (Selasdi) in Iceland, and Fresenius Kabi (Otolpi) in Germany have received FDA approval.

The first to be introduced to the market is Wezlana. It was the first biosimilar to receive FDA approval in November last year and will be launched on January 1 next year. Following that, most other biosimilars, including Pizciba on February 22 and Imuldosa on May 15, will be launched between February and May next year.

Although domestic Stelara biosimilars are expected to be launched later in the U.S. compared to Wezlana, considering the complex distribution process of the U.S. pharmaceutical market, the 'market access strategy after launch' is evaluated as more important than 'early launch.' Even if the launch is delayed, if the biosimilar is listed first on large prescription benefit managers (PBMs), which play a decisive role in drug distribution in the U.S., it can still dominate the market.

In fact, in the autoimmune treatment Humira biosimilar market, where as many as 10 biosimilars compete, Amgen's Amjevita, which was launched first, struggles with only a 1% market share, while Sandoz's Hyrimoz, launched later, holds a 15% market share. Sandoz shows steep growth by successfully partnering directly with PBMs, surpassing Amjevita. The pharmaceutical and bio industry expects that domestic biosimilars can sufficiently target the U.S. market if they succeed in rapid PBM listing, even if their launch is delayed.

Meanwhile, our pharmaceutical and bio companies must also compete with follow-up original drugs in the U.S. market. J&J, the developer of Stelara, is promoting Tremfya, a follow-up drug with the same mechanism of action, but its sales last year were $3.147 billion (approximately 4.192 trillion KRW), still not catching up with Stelara. AbbVie's Skyrizi, an original drug developed with the same mechanism as Stelara, showed sales of $7.763 billion (approximately 10.7129 trillion KRW) last year, a 50% increase compared to the previous year. Eli Lilly's Olumiant also demonstrated superior effects compared to Stelara in Crohn's disease patients. An industry insider said, "If other new drugs show better efficacy, the existing market will inevitably shrink," but added, "Since existing drugs have proven safety over a long period, demand remains solid," and emphasized, "It is necessary to make the market recognize that the quality of biosimilars developed by our pharmaceutical companies is as safe as the originals."