The oncology landscape is approaching a critical inflection point. Between 2028 and 2035, patent protection for the industry’s most significant PD-(L)1 checkpoint inhibitors will expire across global markets. As these “economic anchors” face biosimilar entry, the fundamental benchmarks for oncology pricing and reimbursement are set to be rewritten.
For Pricing and Market Access teams, this transition represents more than a standard loss-of-exclusivity cycle; it is a total reset of the solid-tumor therapeutic landscape
Why This Shift Demands Proactive Strategy
PD-(L)1s currently serve as the backbone of modern cancer care, dictating how entire healthcare budgets are structured. When the net price of these backbones drops, it creates a ripple effect across the entire sector:
- Regional Pricing Divergence: Anticipate varied erosion speeds, from the “fast and deep” hospital tenders of Europe to the stepwise evolution of PBM strategies in the United States.
- The Subcutaneous Wildcard: Early launches of SC formulations are creating “defensive moats,” shifting the value conversation from drug cost to clinic efficiency and patient chair time.
- Combination Therapy Economics: As PD-(L)1 prices fall, the room for innovative add-ons (such as ADCs) expands, but the cost of key clinical benchmarks also falls.
Hear from the Experts at Access Infinity
Access Infinity’s insights, taken from years of working with pharmaceutical and biotech companies on oncology market access strategy, reveal the complexity of this transition. The analysis breaks down the patent cliff timeline, examines how different markets will respond, and explores what this means for manufacturers across the competitive landscape.
What’s Inside the Full Analysis
The analysis covers key aspects of the PD-(L)1 biosimilar transition, including:
- Detailed patent expiry timelines for Keytruda, Opdivo, Imfinzi, and Tecentriq across major markets
- How biosimilar entry will play out differently across Europe, the United States, and Japan
- The role of subcutaneous formulations in the competitive landscape
- Strategic considerations for originator manufacturers, biosimilar developers, and innovators launching combination regimens
- Where PD-(L)1s underperform and areas of opportunity
- Actionable steps to take a proactive approach for pricing and access leaders
Download the Analysis Today
The PD-(L)1 Patent Cliff: What It Means for the Future of Oncology Pricing is a great resource for market access, HEOR and pricing teams navigating lifecycle planning and pricing in oncology. It comes as just one of many expert resources from Access Infinity, including our ‘Market Access Matters’ podcast and Policy Insights. You can also find out more in our on-demand webinars.
Gain deeper insights into the PD-L1 patent cliff and prepare your strategic thinking for the oncology pricing reset. Fill out the form below to receive your copy.
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About the author
George has over eight years’ experience delivering strategic pricing and market access projects, supporting manufacturers with launch excellence planning and lifecycle management. He has worked extensively with companies seeking to commercialise late PD-(L)1 entrants, both as monotherapies and in combination regimens, as well as with manufacturers aiming to compete effectively within crowded oncology markets.
If you have a question or a project in mind, get in touch with George by emailing George@accessinfinity.com or via our contact us page.
