IP4 May 2026 15:58
Biosimilar versions of Keytruda can still be launched in late 2028, as the primary patent protecting the original intravenous (IV) version of the drug is set to expire in December 2028.
However, their immediate success is under threat from Merck’s strategy to shift the market before they arrive.
🔓 Why 2028 is still the "Launch Year"
Despite the new subcutaneous (SC) patents, the path for IV biosimilars remains technically open:
Primary Patent Expiry: The core "composition-of-matter" patent for pembrolizumab (the active ingredient in Keytruda) expires in December 2028 in the US.
Active Pipeline: Multiple companies—including Sandoz, Amgen, and Samsung Bioepis—already have pembrolizumab biosimilars in clinical trials, targeting a 2028-2029 launch.
Regulatory Submissions: Analysts expect the first biosimilar applications to be filed with the FDA as early as 2026 to ensure they are ready for approval the moment the IV patents lapse.
🚧 Challenges to 2028 Biosimilars
While it is legal to make them, three major barriers could limit their impact:
1. The "Subcutaneous Shift"
Merck’s goal is to move 30-40% of patients to the newer, patent-protected subcutaneous version (Keytruda Qlex) before 2028. If successful, biosimilar companies will be fighting over a shrinking "IV-only" market while the most profitable segment remains locked under Merck’s new patents until 2042.
2. Secondary "Thicket" Patents
Merck has filed hundreds of secondary patents covering specific methods of use, manufacturing processes, and dosing schedules.
Some of these patents (e.g., method-of-making) extend into 2029 or beyond.
Biosimilar makers may need to "skinny label" their drugs—launching for only certain types of cancer—to avoid infringing these specific use patents.
FirstWord Pharma
3. Fixed-Dose Combinations
Merck is increasingly testing Keytruda in "fixed-dose combinations" (FDCs), where it is mixed with other drugs in a single vial. These combinations have their own brand-new patents, meaning a biosimilar of "just" Keytruda cannot legally replace an FDC version.
🕒 Expected Timeline for Competition
Late 2028: Expected arrival of the first IV biosimilars in the US.
2029-2030: Rapid price erosion for the IV version as more competitors enter.
2030+: Most market value likely shifts to the subcutaneous version and combinations, where Merck retains exclusivity for another decade.
📍 Key Reality: 2028 marks the end of Merck's total monopoly, but their "subcutaneous shield" ensures they won't lose the entire market to cheaper copies overnight.
PatSnap
Keytruda patent cliff 2028: Merck's strategy - PatSnap
22 Apr 2026 — Merck's Keytruda patent estate extends well beyond the 2028 core expiry through layered method-of-use, formulation, and new fixed-
combinations of Keytruda with Scancell’s Modi-1 or iSCIB1+ (the improved version of SCIB1) can—and often do—receive new patents. While the core patent for Keytruda itself expires in 2