Eight out of ten biologic drugs set to lose exclusivity in Europe still have no biosimilar alternatives in development, according to a new industry report.
The Korea Biopharmaceutical Association released a report titled "Sustainability of Biosimilars: Current Status and Challenges in the European Market" on Thursday, citing data from pharmaceutical market research firm IQVIA. The report found that approximately 100 biologic drugs will lose exclusivity in Europe by 2032, with 79% having no biosimilars currently under development.
Only 10% of these biologics have biosimilar pipelines planned for European market entry, while the remaining 11% have unclear launch prospects. Development is particularly slow for drugs with lower sales volumes or those targeting rare disease areas.
Ophthalmology is a prime example. Ranibizumab, the first biosimilar in ophthalmology, captured only about 40% market share six quarters after launch—well below the 50-60% penetration rates typically seen in other therapeutic areas.
This pipeline gap represents a potential opportunity loss of approximately $143 billion (207 trillion won) in the European market, equivalent to 55% of total sales for biologics facing exclusivity loss.
"Simple price reductions alone are insufficient to drive biosimilar adoption," the report noted. "Non-price factors such as formulation convenience, healthcare professionals' experience, and clinical practice patterns significantly influence adoption decisions in real-world settings."
Korean companies including Celltrion, Samsung Bioepis, and Prestige Biopharma are actively expanding into the European biosimilar market. Of the 28 biosimilars that received European Medicines Agency (EMA) approval recommendations in 2024, 12 were Korean products—the highest share among all countries. This compares to just one Korean product among 41 approved in the previous year.
The report emphasized that structural challenges identified in the European biosimilar industry offer important implications for Korea. It recommended that Korean biosimilar companies pursue strategies beyond blockbuster drugs to capture emerging markets in ophthalmology and dermatology, while improving development efficiency through formulation differentiation and streamlined global regulatory processes.
The report also suggested leveraging accumulated manufacturing capabilities to secure next-generation pipelines such as antibody-drug conjugates (ADCs) and diversifying into emerging markets for long-term growth.
"Continuous monitoring of biologics approaching patent expiry domestically and global pipelines is essential," the report advised. "Building preemptive response systems through industry-academia-research-government collaboration in areas where development gaps are expected could enhance global competitiveness."