Pharmaceutical Firms Expanded Biosimilar Development
Global drugmakers have accelerated biosimilar efforts as major patents approach expiration by 2030.
Updated on Oct. 11, 2026 in Biotech
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Global pharmaceutical companies are ramping up biosimilar production as nearly 200 drugs are set to lose patent exclusivity by 2030. This shift comes as international regulators ease clinical barriers for drug development.
Why it matters
The expiration of patents for blockbuster drugs will open a 400 billion dollar market, prompting companies to fast-track alternatives. Lowered regulatory thresholds are now enabling firms to bypass large-scale efficacy trials to accelerate their pipelines.
The global biosimilar market is projected to reach 151.6 billion dollars by 2033, up from 39.6 billion dollars in 2023. Companies are leveraging regulatory changes to omit large-scale comparative efficacy trials, shortening development timelines.
The players
Samsung Bioepis
This company is a major developer that has launched 11 biosimilars globally.
Celltrion
This firm is currently conducting global Phase 3 trials for multiple biosimilar candidates.
Chong Kun Dang
This pharmaceutical company is advancing development for its Dupixent biosimilar candidate in Europe.
Kyungdong Pharmaceutical
This organization began its dedicated biosimilar development program in late 2025.
The details
Companies including Samsung Bioepis and Celltrion have filed for domestic approvals for Keytruda biosimilars in 2026, while others like Chong Kun Dang are advancing Ocrevus and Dupixent equivalents. Development strategies now focus on reducing patient enrollment in Phase 3 trials to speed up time-to-market.
Timeline
December 2025: Kyungdong Pharmaceutical began biosimilar development.
January 2026: Chong Kun Dang received Europe trial approval.
August 2026: Samsung Bioepis and Celltrion applied for domestic approvals.
September 2026: Celltrion received trial modification approval.
Early 2027: Expected results for CT-P53 Phase 3 trials.
The Tech Race
The shift toward accelerated biosimilar development mirrors the broader industry race to capture market share from expiring patents. This move positions generic-focused firms to compete directly with legacy manufacturers by replacing high-cost treatments with more accessible alternatives.
Patients may eventually see lower out-of-pocket costs for essential medications as more biosimilars enter the market. Increased product availability could expand access to specialized treatments that were previously cost-prohibitive due to patent protections.
The takeaway
The rise of biosimilar development signals a major transition in the pharmaceutical sector toward broader accessibility. Readers should monitor upcoming regulatory approvals, as these will likely determine the timeline for reduced pricing on key specialty drugs.
Further reading
For more information on industry trends, see the Biotech section.
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Do you believe the expansion of generic biosimilar drugs will lower your household medical costs?
