Firms Expanded Biosimilar Pipelines Amid Patent Cliffs
Global drug manufacturers accelerated biosimilar development as roughly 200 blockbusters face patent expiration by 2030.
Updated on Oct. 11, 2026 in Biotech
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Pharmaceutical firms have ramped up efforts to develop biosimilar drugs as high-value original therapies lose their market exclusivity. Berenberg estimates that drugs set to lose patents by 2033 account for 400 billion dollars in annual sales.
Why it matters
Regulatory shifts in the U.S. and Europe have lowered barriers for entry, allowing manufacturers to move faster as massive revenue streams open for competition. This acceleration positions the biosimilar market to grow from 39.6 billion dollars in 2023 to a projected 151.6 billion dollars by 2033.
Regulators have permitted the omission of large-scale comparative efficacy trials, leading firms like Celltrion to reduce clinical trial patient counts to expedite development.
The players
Celltrion
A biopharmaceutical firm specializing in monoclonal antibody development with a growing global biosimilar portfolio.
Samsung Bioepis
A developer of biosimilar medicines that has launched 11 products globally since its inception.
Chong Kun Dang
A Korean pharmaceutical company expanding its reach into global biosimilar clinical trials.
Kyungdong Pharmaceutical
A regional drug manufacturer that began investing in biosimilar development in late 2025.
The details
Biosimilars are highly similar versions of biologic drugs—therapies manufactured in living systems rather than synthesized chemically. By demonstrating analytical sameness to an original biologic, companies can bypass the exhaustive clinical efficacy trials required for new molecules. Celltrion recently modified its U.S. Phase 3 trial protocols for the Ocrevus biosimilar candidate, CT-P53, to streamline the process for reaching the market.
Timeline
December 2025: Kyungdong Pharmaceutical began development of a Dupixent biosimilar.
January 2026: Chong Kun Dang received approval to conduct Phase 1 trials for its Dupixent candidate in Europe.
August 2026: Samsung Bioepis and Celltrion filed for domestic approvals of their Keytruda biosimilar candidates.
September 2026: Celltrion received authorization to modify its U.S. Phase 3 trial plan for CT-P51.
Early 2027: Initial results are expected for the Ocrevus biosimilar candidate CT-P53.
The Tech Race
The industry is shifting from a landscape dominated by a few established biosimilar players to a crowded field of competitors targeting the same expiring patents. This race is defined by manufacturers attempting to shorten development timelines through regulatory shortcuts and increased clinical trial efficiency.
Patients and healthcare providers can expect a wider range of lower-cost therapeutic options as these biosimilars clear clinical and regulatory hurdles. The transition to clinical use will occur as firms move their pipeline candidates through trials toward the commercial phase.
The takeaway
The next five years will be defined by the race to capture market share from expiring blockbuster biologics like Keytruda, Ocrevus, and Dupixent. Watch for the initial Phase 3 results for CT-P53 in early 2027, which will serve as a bellwether for the success of truncated trial designs.
Further reading
For more on the latest research and regulatory shifts in the pharmaceutical sector, explore our coverage of Biotech.
Source note: This article includes information reported by 조선일보.
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