The Cancer Patent Cliff Playbook: Turning $60B+ Revenue Risk into Biosimilar Revenue Risk into Biosimilar Upside

Updated: Aug 14

Between 2025–2028, Merck’s Keytruda (pembrolizumab) and BMS’s Opdivo (nivolumab)—together generating approximately $38B+ in annual sales—seriously risk losing patent protection (Keytruda expires in 2028, Opdivo by 2027). These two drugs alone account for nearly $60–70B of global oncology revenue at risk from biosimilar competition.

Fast‑growing biosimilar players—Sandoz, Biocon Biologics, Amgen, Celltrion, and Dr. Reddy’s/Alvotech—are staking first-mover advantage with late‑stage PD‑1, PD‑L1, and HER2 biosimilar filings and licensing deals, just in time for the 2026–27 launch window. Meanwhile, the global oncology biosimilars market, valued at ~$6.8B in 2024, is projected to reach $21.1B by 2030 (≈20.3% CAGR), as originators accelerate switch-era life-cycle strategies.

For investors, watch these signal events: BLA/interchangeability filings for pembrolizumab and nivolumab (2026–27); FDA approvals like Biocon’s “Jobevne” bevacizumab (Apr 2025); and pricing benchmarks vs originator net cost post-launch. With new regulatory tailwinds—especially the FDA’s 2024 guidance reducing clinical barriers—biosimilar innovators can rapidly seize share in the switch‑phase healthcare landscape.

EliteAge Research and analytics operates as a boutique investment-intelligence boutique specializing in cancer-patent expiry and biosimilars.

- It tracks drug & secondary patent expiry by region (US, EU, Japan, India), cross‑linked to last full‑year sales

-Tracks global biosimilar filings in development (US/EMA/India regulators)

-Competitor & Biosimilar Benchmarking Module

For more details connect to info@eliteageresearch.co.in. www.elteageresearch.co.in

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