The biosimilar market is entering its most commercially consequential phase — the loss of exclusivity for adalimumab (Humira, $20B peak), ustekinumab (Stelara), and the approaching patent cliff for pembrolizumab (Keytruda) and nivolumab (Opdivo) will create biosimilar competition for the world's highest-revenue biologics. Teva's biosimilar portfolio — encompassing over 35 approved biosimilars across oncology, immunology, and neurology — is one of the largest in the industry. Amgen's biosimilar business generated over $2 billion in 2025 revenue. The transition from reference biologic to biosimilar is being accelerated by payer formulary exclusions and interchangeability designations.
This report provides significant competitor information, analysis, and insight critical to the development and implementation of effective marketing and R&D programs.
Topics Covered
• Biosimilar Market Dynamics
• Humira Biosimilar Competition
• Stelara Loss of Exclusivity
• Keytruda Patent Cliff
• Teva and Amgen Biosimilar Strategies
• Interchangeability Designations
• Biobetter Development
• Competitive Landscape
Table of Contents
1. Executive Summary
2. Market Overview
3. Biosimilar Market Dynamics
4. Humira Biosimilar Competition
5. Stelara Loss of Exclusivity
6. Keytruda Patent Cliff
7. Teva and Amgen Biosimilar Strategies
8. Interchangeability Designations
9. Biobetter Development
10. Competitive Landscape
11. Competitive Landscape
12. Regional Market Analysis
13. Strategic Conclusions and Recommendations
14. Appendix
List of Tables
Table 1. Market Overview and Key Data 2025
Table 2. Competitive Landscape 2025
Table 3-8. Topic-Specific Analysis Tables
Table 3. Leading Companies — Portfolio and Strategy Assessment 2025
Table 4. M&A and Partnership Activity 2023-2025
Table 5. Pipeline Assessment 2025
Table 6. Key Risks and Mitigation Strategies
Companies Profiled
Sandoz
Celltrion
Samsung Bioepis
Coherus
Organon
Amneal
Viatris
Fresenius Kabi
