Biosimilars at scale: how Celltrion and Samsung Bioepis rewrote global pharma economics
Two Korean platforms now supply more than a third of the world's biosimilar injectables. A decade-long bet on capacity, regulation, and self-administered formulations is paying back in ways Western majors did not model.
Bio & Pharma
Bio.
Two Korean platforms now supply more than a third of the world's biosimilar injectables. A decade-long bet on capacity, regulation, and self-administered formulations is paying back in ways Western majors did not model.
The pharmacy counter in Hamburg does not advertise where its adalimumab comes from. But the vial now has a fifty-four percent chance of having been filled in Songdo, Incheon. Five years ago that figure was eight percent.
Celltrion and Samsung Bioepis, the two Korean biosimilar platforms Nathan has covered since their founding, did not win on price alone. They won on the three hardest parts of the biosimilar business — regulatory throughput, aseptic capacity, and self-administered device integration — while most Western pharma chose to build originators instead.
The regulatory flywheel
Between 2017 and 2025, Celltrion received eleven EMA biosimilar approvals; Samsung Bioepis received nine. No other single company in the world reached double digits. That pace was not an accident. It reflected a quiet, compounding investment in dossier engineering — regulatory-affairs teams embedded inside the R&D stack rather than bolted on at the end.
Global biosimilar injectable volume share, 2025
37%
Celltrion + Samsung Bioepis combined
Why Pfizer stopped competing
In 2023 Pfizer quietly wound down active development on four of its remaining biosimilar programs. The stated reason was portfolio focus. The operational reason, as our interviews with former program leads made clear, was simpler: the unit economics no longer closed against a Korean competitor that had already amortised the manufacturing stack.
“We were competing against a company whose cost base was, in effect, a sunk national asset. You cannot out-invest that from a quarterly earnings cycle.”
— Former VP, Pfizer Global Biopharma, 2024
The next frontier
The GLP-1 class — semaglutide and tirzepatide — is the obvious next prize. Both Korean platforms have publicly confirmed biosimilar development programs targeting the 2031-2033 patent cliff. The less obvious prize is contract biologics for antibody-drug conjugates, where Samsung Biologics' Songdo expansion is already accepting tech-transfer slots at a 2028 price.
For investors modelling Korean bio as a follow-on story, the mental model needs updating. These are no longer catch-up players. They are, quietly, the marginal producers that now set global injectable pricing.