Europe is expected to see patents expire on about 100 biologic drugs over the next six years, but 79% of them have no biosimilar versions currently in development, a report found.
The Korea Bio Medicine Association said in a report released on the 22nd, citing IQVIA and other sources, that exclusive rights for about 100 biologics in Europe will end by 2032.
Even so, 79% have no biosimilars in development. Biosimilar pipelines slated for Europe accounted for just 10%, while 11% had unclear prospects for local launch. The report said limited development for lower-revenue products and rare-disease treatments has created a structural “biosimilar development gap.”
That gap could translate into an estimated $143 billion (about 207 trillion won) in missed opportunities in Europe, the report said — equal to 55% of total sales for biologics nearing patent expiration. It added that even high-selling biologics do not have enough biosimilar development underway.
The report urged South Korean companies to keep focusing on blockbuster products with annual sales in the trillions of won while also moving early to secure biosimilar markets in new therapeutic areas such as ophthalmology and dermatology. It also recommended improving development efficiency through differentiated formulations and by taking advantage of simplified global regulations.
As of 2024, South Korean companies including Celltrion, Samsung Bioepis and Prestige Biopharma accounted for 12 of the 28 biosimilars that received a recommendation for approval from the European Medicines Agency, the report said, the most of any country. Of the 41 products recommended last year, one was from Celltrion.
“Building a preemptive response system through cooperation among industry, academia, research institutes and government in areas where development gaps are expected will contribute to the sustainability of the domestic biosimilar industry and strengthen global competitiveness,” the report said.
* This article has been translated by AI.
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