Bio-Thera Solutions Declares Global Ambition with FDA Approval of STARJEMZA™, Challenging J&J's $10.3B Stelara Franchise

On May 23, Bio-Thera Solutions, Ltd. announced that its ustekinumab biosimilar BAT2206, branded as STARJEMZA, has been officially approved by the U.S. FDA for the treatment of moderate to severe plaque psoriasis in adults and children, active psoriatic arthritis, Crohn's disease, and ulcerative colitis. This marks a significant breakthrough for Chinese biosimilars entering the global market.

The "going global" of biosimilars is never as simple as "obtaining approval." The path, landscape, and博弈 behind BAT2206 are the truly noteworthy focal points.

Stelara® was launched by Johnson & Johnson in 2009 as a biologic targeting the IL-12/23 pathway, and has been cumulatively approved for multiple indications including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.In 2023, Stelara's global sales reached a staggering $10.858 billion. In 2024, sales declined slightly to approximately $10.361 billion, but this "over $10 billion" market remains highly valuable.As the patent expires in 2023, this "multi-billion-dollar" market opens up, but Johnson & Johnson reinforces its position through multiple defenses.

1. Control the Pace of Biosimilars: Reached settlements with companies like Amgen to delay the market entry of biosimilars and control the pace of competition.

2. Indications Expansion and Product Optimization: Advance the research on first-line treatment for Crohn's disease and build a product portfolio through the new-generation drug Tremfya; the original drug expands its indications in China to include pediatric psoriasis.

3. Market and Channel Advantages: The U.S. healthcare insurance system does not mandate the substitution of biosimilars, and doctors' prescribing habits, along with PBM (Pharmacy Benefit Management) contracts, may slow down the loss of market share for originator drugs. However, the cost advantage of biosimilars might gradually change the landscape.

Bio-Thera's ustekinumab biosimilar BAT2206 (STARJEMZA®) has received FDA approval, but its commercialization path remains challenging.

BAT2206 to Be Exclusively Marketed by Hikma Pharmaceuticals in the U.S., but Significant Challenges Lie Ahead, Including PBM Access, Physician Education, Patient Awareness, and Other Barriers. Clinically, Phase III trial results of BAT2206 in patients with moderate-to-severe plaque psoriasis showed its PASI 75 response rate to be equivalent to the originator drug Stelara®, with no significant difference in immunogenicity, ultimately gaining FDA recognition as a highly similar biosimilar.

However, in the U.S. market, BAT2206 is not entering an open field. To date, several Stelara biosimilars have already been approved, and the market landscape is beginning to take shape. The original drug, Stelara, is priced as high as $19,212 per 45mg dose in the U.S., while Celltrion has publicly stated that its biosimilar will be priced at approximately $3,000 upon launch, offering a discount of nearly 85%. Such "deep discounts" have almost become the standard strategy for biosimilars in the U.S. If Bio-Thera wants to break through, it must not only adopt a pricing strategy that demonstrates sincerity but also leverage its partner’s long-term channel and market accumulation to secure a place in this fiercely competitive "multi-billion-dollar" market.

Currently, BAT2206 is still in the review stage in China, lagging behind Huadong Medicine's "Sailuoxin" (which was launched in 2023). However, Bio-Thera has not prioritized the Chinese market as its primary breakthrough point. Instead, it has chosen to first conquer the United States, demonstrating its quality and compliance capabilities to the world.

On this basis, BAT2206 has partnered with Gedeon Richter (EU), Tabuk (Middle East), Biomm (Brazil), Dr. Reddy’s (Southeast Asia and Colombia), and others to expand its reach across Europe, the Americas, and emerging markets. Through "global endorsements," it aims to enhance its pricing power and recognition in future negotiations for inclusion in China's national medical insurance system.

Of course, this "export-to-domestic-sales" strategy also faces challenges—on the one hand, high overseas pricing may become a psychological anchor point for future medical insurance negotiations; on the other hand, the acceptance of "international endorsement" by domestic patients in China is uncertain, and whether they are willing to pay a premium for it still needs to be verified by the market.

As the patent barriers for Stelara® begin to weaken, the global market is entering a new phase of "patent life extension by the originator, overseas substitution, and domestic breakthroughs" with a three-way battle. Johnson & Johnson is striving to maintain its core market share through authorized partnerships and product upgrades; meanwhile, companies like Amgen, Samsung, and Bio-Thera are accelerating the push for biosimilar substitution in European and American markets. In China, Huadong Medicine's "Sailoxin" has taken the lead in launching, followed closely by Bio-Thera and CSPC, rapidly heating up the competition.

In the future, the winner will not be determined by who goes public first, but by who can leverage international quality and cost advantages to打通PBM,医生, and 患者 channels, building a closed-loop capability in indication coverage, commercial execution, and医保 negotiation to seize market dominance.

The significance of BAT2206 lies not only in becoming the first Chinese Stelara biosimilar to gain full approval in the U.S., but also in representing whether Chinese biopharmaceutical companies are capable of mastering the entire chain system of "global registration-regional collaboration-price management-local implementation."

In the next decade, the biosimilar market will not be a case of "bad money driving out good," but rather "system strength determines the ceiling." Although Bio-Thera has fired the first shot in its overseas expansion, the real market battle has just begun.

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