Chinese and Indian companies won a string of biosimilar (copycat biologic drug) approvals in the U.S. and European Union this year, while South Korean companies failed to secure a single one, according to industry data. Analysts, however, describe the gap as a temporary pause as South Korean firms focused on expanding sales of existing products and developing follow-on pipelines, with approval decisions on biosimilars of the immuno-oncology drug Keytruda from next year expected to mark a turning point for a rebound.
According to data recently released by the Korea Biotechnology Industry Organization, none of the biosimilars approved in the U.S. and EU this year, as compiled by BioPharma APAC, were South Korean-made. Of the nine biosimilars the U.S. Food and Drug Administration (FDA) approved from January to September, seven came from Asia-Pacific companies, and 10 of the 12 the European Commission approved through the end of July were also from the region. All 17 of those products, however, were developed by Chinese and Indian companies, with China accounting for eight approvals and India nine.
“Indian companies delivered results in approval volume, while Chinese companies made their mark with firsts,” the organization said. Indian firms won approvals in areas where product families already exist, including three for the eye-disease treatment ranibizumab and one for the bone-disease treatment denosumab. Four of the eight approvals for Chinese companies broke new ground, including the first golimumab biosimilar in the U.S. and the first pertuzumab biosimilar in Europe. Golimumab treats autoimmune diseases, while pertuzumab is a breast cancer treatment.
South Korea’s leading biosimilar developers are Celltrion (068270.KS) and Samsung Bioepis. Celltrion has four pipeline candidates in Phase 3 clinical trials, including the Keytruda (active ingredient pembrolizumab) biosimilar CT-P51 and CT-P44, a biosimilar of the multiple myeloma treatment daratumumab. Samsung Bioepis is also studying nine candidates, including the Keytruda biosimilar SB27 and SB35, a biosimilar of the psoriasis treatment ixekizumab.
BioPharma APAC noted that neither company had any approvals this year but cautioned against reading that as a “retreat.” Both won copycat approvals in 2024-2025 for several biologics, including ustekinumab, denosumab, tocilizumab and omalizumab, and this year was a period of preparation for the future, according to the report. Indeed, Samsung Bioepis said in its third-quarter earnings presentation that the ustekinumab biosimilar SB17 drove growth, while Celltrion said sales of its version, Steqeyma, are steadily rising in the U.S. The publication said the two companies pioneered a business model of mass-producing products in Asia and exporting the commercial rights to partners with Western distribution networks, positioning them as trailblazers among Asia-Pacific biosimilar makers.
The key going forward is the Keytruda biosimilar both companies are preparing. Samsung Bioepis said it filed for South Korean approval of SB27 with the Ministry of Food and Drug Safety in August — the first by a South Korean company — and applied for FDA approval on the 30th. It is the first publicly disclosed U.S. approval filing for a Keytruda biosimilar developed by a South Korean company. Celltrion filed for South Korean approval of CT-P51 on the 21st of the same month and plans to expand filings to the U.S., Europe and Canada.
Keytruda is an immune checkpoint inhibitor developed by U.S. drugmaker Merck (MSD) that binds to the PD-1 protein to block cancer cells’ immune evasion. It has won broad indications including melanoma, non-small cell lung cancer and head and neck cancer, and SB27’s U.S. application covers 18 indications. Samsung Bioepis conducted a Phase 1 trial in 163 patients across four countries and a Phase 3 trial in 555 patients across 14 countries starting in 2024, confirming equivalence with the original drug, and plans to complete both trials within the year.
Note: Based on MSD earnings reports. First-half sales rose 8.2% from a year earlier.
Global competition has already begun. FYB206, a Keytruda biosimilar co-developed by Germany’s Formycon and India’s Zydus Lifesciences, had its application accepted for review by the FDA on the 13th of this month. The companies described it as the first publicly disclosed case of the FDA accepting a Keytruda biosimilar application for review.
The market is expected to open in earnest after 2028, when key patents on the original drug expire. In its annual report filed with the U.S. Securities and Exchange Commission, MSD said Keytruda’s main U.S. substance patent expires in December 2028 and that biosimilar competition in 2028-2029 is expected to significantly affect sales. Some related patents, however, run through 2029, so the actual launch timing could vary depending on patent disputes and other factors.
Shin Dong-hoon, head of clinical medicine at Samsung Bioepis (vice president), said, “Through the U.S. review process for SB27, we will once again demonstrate our R&D capabilities and work to expand treatment options and improve accessibility for patients through biosimilars in immuno-oncology.”
Some in the industry say it is too early to conclude that this year’s weak approval record reflects a structural disadvantage. “The low number of South Korean biosimilar approvals this year doesn’t seem to mean much,” one bio industry official said. “Once Keytruda biosimilars developed by South Korean companies are approved, they will be able to sustain growth based on existing distribution networks and marketing experience.”
The key variables are the review timeline and patent barriers. Keytruda is a blockbuster with annual sales of around 40 trillion won (approximately $30.0 billion) from a single drug, so approval would mark a shift in the revenue base of South Korea’s biosimilar industry from autoimmune diseases to cancer drugs. At the same time, Chinese and Indian companies are racking up both approval volume and first-entry records, suggesting price competition and battles to secure distribution in the U.S. and European markets will only intensify.
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