Biocon Biologics’ YESINTEK Secures Dominant U.S. Market Access Amid Stelara Biosimilar Surge

Biocon Biologics’ newly approved biosimilar YESINTEK™ (ustekinumab-kfce) has made a swift and strategic entry into the U.S. market, securing coverage for over 100 million lives within months of its FDA approval. The drug, a copy of Janssen’s blockbuster Stelara® (ustekinumab), has leveraged rapid formulary inclusions to position itself as a cost-effective option in a crowded autoimmune drug landscape. But with seven Stelara biosimilars now competing for market share, the question remains: can YESINTEK carve out a durable advantage?

Ask Aime: Can YESINTEK™ carve out a durable advantage in the U.S. market amidst Stelara biosimilars?

The Formulary Blitz
YESINTEK’s launch strategy has centered on swift formulary access, a critical factor in biosimilar adoption. By early 2025, it secured coverage across major U.S. payers:
- Express Scripts and Cigna added YESINTEK to their formularies by March 2025.
- UnitedHealthcare granted access across commercial, Medicaid, and Medicare plans by June 2025.
- CVS Health and Optum Rx followed with inclusions by July 2025, placing YESINTEK in premium tiers.

Ask Aime: Can Biocon Biologics' YESINTEK™ outperform Janssen's Stelara®?

Combined, these agreements cover 70–80% of the commercial market. Biocon’s emphasis on patient support, including $0 copays for eligible individuals, further amplifies its appeal in a market where out-of-pocket costs often dictate treatment choice.

A Crowded Field, but Strategic Pricing Power
YESINTEK’s timing is both advantageous and perilous. The FDA has now approved seven Stelara biosimilars for 2025, with discounts potentially reaching 80% off Stelara’s list price. This pricing pressure has already begun reshaping the market: insurers are increasingly favoring biosimilars over the originator, which could lose its formulary position in some plans.

For Biocon, the challenge is twofold. First, it must differentiate YESINTEK in a sea of similar products. Its Phase 3 trial data (the STELLAR-2 trial) and interchangeability status (pending but likely) will be key. Second, it must navigate the razor-thin margins common in biosimilar markets.

The Investment Case: Risks and Rewards
The U.S. biosimilar market is projected to grow at a 10% CAGR through 2030, driven by expiring patents for drugs like Stelara. YESINTEK’s early formulary wins and patient assistance programs suggest it could capture a meaningful slice of this pie. However, the sheer number of competitors—Amgen’s Amjevita, Mylan’s Erelzi, and others—adds volatility.

Biocon’s stock (NSE: BIOCON) has risen 15% since the FDA approval in December 2024, reflecting investor optimism. Yet, the real test comes in the next 12–18 months, as the market sorts out pricing tiers and patient uptake. Analysts at Bernstein estimate that YESINTEK could generate $300–500 million in annual U.S. sales by 2027, assuming 20–30% market share.

Conclusion: A Strong Hand, but the Game Isn’t Won Yet
YESINTEK’s rapid formulary access and strategic pricing are clear positives for Biocon. The drug’s early adoption by 70% of the commercial market positions it well to capitalize on Stelara’s patent cliff. However, the market’s crowded state and insurers’ cost-cutting zeal mean Biocon must maintain aggressive pricing and clinical differentiation.

The data tells the story: with over 100 million lives covered and a 80% price discount potential, YESINTEK is already a formidable player. Yet, success hinges on Biocon’s ability to sustain this momentum in a fiercely competitive landscape. For investors, this is a high-risk, high-reward bet on a company poised to lead—or at least survive—the next wave of biosimilar disruption.