By 2032, about 100 biopharmaceuticals are expected to lose their patents in the European market, and..

Investigation by the Korea Biopharmaceutical Association
“K-Bio to preempt the market”

*[Photo = Korea Biopharmaceutical Association]*

By 2032, about 100 biopharmaceuticals are expected to lose their patents in the European market, and about 79% of them do not yet have a “biosimilar (biopharmaceutical replication drug),” according to a survey. It is advised that Korean companies should focus on blockbusters and dominate the biosimilar market in new treatment areas such as ophthalmology and dermatological disease treatments.

About 100 biopharmaceuticals will lose their monopoly in Europe by 2032, according to a report titled “Sustainability of Biosimilars-The Current Status and Challenges of the European Market” published by the Korea Biopharmaceutical Association on the 22nd, citing pharmaceutical market research firm IQVIA. Of these, 79% or 8 out of 10 did not have biosimilars under development.

Only 10% of biopharmaceuticals have biosimilar pipelines scheduled to enter Europe, and the remaining 11% are unclear whether they will launch in Europe. In the case of low sales or rare treatment areas, biosimilar development is particularly slow, according to the survey.

For example, the first biosimilar in the ophthalmology field, “Ranivizumab,” accounted for only about 40% of biosimilars six quarters after its launch. This is low compared to the biosimilar share (50-60% or more) observed in a number of treatment areas, the report declared.

The biosimilar pipeline gap is estimated to potentially cost about $143 billion (about 207 trillion won) in the European market. This is 55% of the total sales of biopharmaceuticals ahead of the loss of monopoly rights.

“It is difficult to induce the adoption of biosimilars only by simple price cuts,” the report declared. “Factors other than the price, such as the convenience of the formulation, the experience of utilizing medical staff, and the method of treatment, have a significant impact on whether they are actually adopted in the clinical field.”

The report emphasized that the structural challenges of the biosimilar indusattempt identified in European cases also provide important implications for Korea.

Along with blockbuster-oriented strategies, Korean biosimilar companies required to dominate the biosimilar market in new treatment areas such as ophthalmology and dermatological disease treatments, and improve development efficiency utilizing differentiation of formulations and simplification of global regulations.

Based on the production capabilities accumulated so far, it was also suggested that the foundation for long-term growth should be strengthened by securing next-generation pipelines such as antibodies and drug conjugates (ADC) and diversifying emerging markets.

“We required to continue to monitor biopharmaceuticals and global pipelines that are scheduled to expire in Korea,” the report declared. “If we establish a preemptive response system through indusattempt, academia, research, and government cooperation in areas where development gaps are expected, we can increase global competitiveness.”

In Korea, Samsung Bioepis and Celltrion are tarobtaining the European biosimilar market. Of the 28 biosimilars recommfinished by the European Medicines Agency (EMA) for 2024, 12 were South Korean company products, which accounted for the highest proportion. Last year, one out of a total of 41 licensed recommfinished products was domestic.

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