Celltrion's Global Biosimilar Strategy: Can the Keytruda Biosimilar Be a Game Changer?

With Celltrion completing its Keytruda biosimilar FDA submission, we analyze whether approval could open a ₩10 trillion revenue era.

🤖 AI Analysis•2026年2月2日 22:30

Biosimilar Market Overview

The global biosimilar market has grown to approximately $68 billion as of 2025 and is projected to reach $120 billion by 2030. The biosimilarization of immune-oncology and autoimmune disease treatments is emerging as the next growth driver.

Celltrion's Pipeline

Launched Products

Remsima (infliximab): Surpassed ₩5 trillion in cumulative global sales, Celltrion's cash cow

Truxima (rituximab): Stable sales growth in European and US markets

Yuflyma (ustekinumab): Stelara biosimilar launched in 2025

New Pipeline

CT-P43 (Keytruda biosimilar): FDA BLA submission completed, targeting 2027 launch

CT-P47 (Keytruda SC): Differentiated with subcutaneous formulation

CT-P59 (adalimumab): Humira biosimilar, preparing for market entry

Keytruda Biosimilar Impact

Keytruda (pembrolizumab) is the world's highest-revenue drug with annual sales exceeding $25 billion. When biosimilars launch:

Biosimilars expected to capture 30-40% of market post-patent expiry

If Celltrion enters as first mover, ₩3-5 trillion in additional annual revenue possible

US insurers' expanding biosimilar-first prescription policies are positive

Risks

Potential additional clinical requirements during FDA review

Aggressive patent defense litigation from Merck (MSD)

Multiple biosimilar competitors (Samsung Bioepis, etc.)

Investment Opinion

Keytruda biosimilar approval is the key variable determining Celltrion's mid-to-long-term enterprise value. Current share price appears to reflect only ~50% success probability, suggesting 30%+ upside potential upon FDA approval.

Rating: Buy (Target Price: ₩250,000)

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💡Methodology

This analysis is auto-generated by AI combining investment bank reports, earnings data, market data, and news sentiment. Not investment advice.

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