Drugmakers race to capture Keytruda biosimilars as MSD shifts to SC
Pharmaceutical companies like Samsung Bioepis, Formycon, Zydus, Celltrion, and Amgen are racing to develop biosimilars for MSD's top-selling cancer drug Keytruda, as its patent nears expiration. Samsung Bioepis filed for FDA approval, while Formycon and Zydus are already under review. MSD is defending its market with a new subcutaneous formulation, Keytruda Qlex, and plans to acquire new drugs.
How this was made
The 30-second read
Why it matters
The race to secure FDA approval could reshape market share in the checkpoint inhibitor segment.
Market read
First‑report FDA filings and trial results create new catalysts for both incumbents and challengers in oncology.
What to watch
The SC formulation could retain a portion of Keytruda's market share, mitigating biosimilar impact on MRK.
Background
Keytruda's patent expiry is imminent, prompting multiple companies to file biosimilar candidates with the FDA.
Ticker impact
Amgen reported positive phase‑3 results for its Keytruda biosimilar and plans a filing in the second half of the year.
potential upside as the market anticipates a new product launch
First public disclosure of trial success and upcoming filing provides a catalyst for AMGN.
Market effects
Accelerates competition in the oncology biosimilar space, pressuring incumbent immunotherapy makers.
Korean and Indian biotech firms may gain visibility, influencing Asian biotech indices.
Adds to global pipeline of high‑cost cancer therapy alternatives, affecting worldwide oncology spend.
Counterpoint
Biosimilar approvals may be delayed by regulatory hurdles, limiting near‑term upside for AMGN and others.
Key entities
- CompanyMerck & Co.
Developer of Keytruda, facing patent expiry and launching a subcutaneous version.
- CompanyAmgen Inc.
Biotech firm with a Keytruda biosimilar candidate showing positive trial data.
