Chinese and Indian developers have won 17 biosimilar approvals in the United States and European Union so far in 2026, while South Korean companies have won none, Chosunbiz reported on 1 November. Korea's two biosimilar leaders, Samsung Bioepis and Celltrion, are now betting on copies of MSD's cancer immunotherapy Keytruda (pembrolizumab).
The headline figure needs context. Korea is not new to biosimilars: Celltrion and Samsung Bioepis hold more than 20 EU biosimilar authorisations between them. The "zero" refers only to new approvals granted this calendar year. For patients and health systems, including Ireland's, the bigger story is the race to copy Keytruda, one of the most widely used cancer medicines in the world, as its main patent protection runs out.
- The count: 17 US and EU biosimilar approvals in 2026 for Chinese (8) and Indian (9) developers, and none for Korean developers, according to Chosunbiz and a matching tally by Biopharma APAC.
- Our check: no 2026 entry on the FDA's biosimilar list and no 2026 EU biosimilar authorisation in EMA data belongs to a Korean company.
- Keytruda: MSD's 2025 annual report says US biosimilar competition could begin in December 2028, when the primary compound patent expires.
- Korean candidates: Samsung Bioepis (SB27) has filed in Korea and the US; Celltrion (CT-P51) has filed in Korea.
- Ireland: EMA product information lists MSD's Swords, Co Dublin plant as a Keytruda active-substance manufacturer.
1. What "17 versus zero" actually counts
According to Chosunbiz, citing industry data, all 17 biosimilars approved this year in the US and EU for Asian developers came from Chinese and Indian companies. A separate tally by Biopharma APAC, verified to 27 October, reaches the same numbers: nine decisions for Indian developers and eight for Chinese developers, made up of seven FDA licences and ten European Commission decisions. A product approved in both regions counts twice.
The products are mostly older, high-volume biologics: insulins from Gan & Lee, Sunshine Lake and Tonghua Dongbao, ranibizumab eye injections from Lupin and Intas, golimumab from Bio-Thera, denosumab from Enzene, etanercept from Biocon, pertuzumab from Henlius and rituximab from Dr. Reddy's.
We checked the claim against the regulators' own lists. The FDA's biosimilar product information page, current to 28 October 2026, lists nine 2026 entries. Two went to non-Asian companies, Teva (denosumab) and Xbrane of Sweden (ranibizumab, approved in October), and none to a Korean developer. EMA's medicines data, generated on 2 November 2026, shows 14 biosimilars with a 2026 EU marketing authorisation date. None is held by Samsung Bioepis or Celltrion.
The same EMA data shows how established the Korean companies already are: 12 authorised EU biosimilars held by Celltrion and 11 by Samsung Bioepis. Their most recent EU approvals date from 2025, including copies of denosumab, aflibercept and tocilizumab. So "zero" describes a quiet 2026, not an absence from the market.
2. Why Keytruda matters
Keytruda is a PD-1 inhibitor, an immunotherapy that helps the immune system attack tumours. It is approved for many cancers, including melanoma, lung cancer and head and neck cancer, and is a mainstay of hospital oncology across Europe.
In its annual report for 2025, filed with the US Securities and Exchange Commission on 24 February 2026, MSD (known as Merck & Co. in the US and Canada) said US biosimilar competition could begin in December 2028, when the primary compound patent expires. We could not confirm an EU expiry date from an official source; published estimates vary, and supplementary protection certificates differ by country. MSD has also developed a subcutaneous version, sold in the US as Keytruda Qlex, which is protected separately.
3. Who is developing Keytruda biosimilars
Samsung Bioepis ran its Phase 1 and Phase 3 trials of SB27 in parallel from 2024. It applied to Korea's Ministry of Food and Drug Safety on 10 August 2026, the first Keytruda biosimilar application in Korea, and announced a US FDA application on 30 October covering 18 indications, according to Korean press reports. An EU filing has not been disclosed.
Celltrion announced on 24 August that it had applied to the Korean regulator for CT-P51, based on a 228-patient study in melanoma patients after surgery that it says showed equivalent drug exposure to Keytruda. It plans to file next in the US, Europe and Canada. Its lung cancer trial is still running.
The first Keytruda biosimilar application publicly confirmed as accepted by the FDA is not Korean. Formycon of Germany and its US partner Zydus Lifesciences of India said on 13 October that the FDA had accepted FYB206 for review, with a decision expected in the third quarter of 2027.
| Developer | Candidate | Stage |
|---|---|---|
| Samsung Bioepis (Korea) | SB27 | Phase 3, 555 patients in 14 countries (NCT06348199); filed in Korea and the US |
| Celltrion (Korea) | CT-P51 | Phase 3 in lung cancer, 225 patients (NCT06939595); filed in Korea |
| Formycon (Germany) with Zydus (India) | FYB206 | US application accepted for FDA review |
| Sandoz (Switzerland) | GME751 | Phase 1 and Phase 3 studies completed (NCT06159790) |
| Amgen (US) | ABP 234 | Phase 3, 315 patients (NCT06311721) |
| mAbxience (Spain) | MB12 | Phase 3, 726 patients (NCT06687369) |
| Henlius, Bio-Thera, Qilu (China) | HLX17, BAT3306, QL2107 | Phase 1 to Phase 3 studies listed |
4. What it means for Ireland and the EU
Any Keytruda biosimilar sold in Ireland would go through EMA's centralised procedure, with a European Commission decision valid across the EU. EMA and the Heads of Medicines Agencies have confirmed that EU-approved biosimilars are interchangeable with their reference medicine.
Ireland also has a stake on the manufacturing side. Keytruda's EU product information lists MSD International GmbH at Drynam Road, Swords, Co Dublin, as one of the manufacturers of the active substance. MSD Ireland says its Dublin biotech site makes biologics, including immuno-oncology medicines, and that its Brinny site in Co Cork tests immuno-oncology medicines. The same EMA list includes Samsung Biologics in Songdo, Incheon, which shows how closely Korea is already tied to Keytruda's supply chain. See our MSD Ireland company profile and pembrolizumab drug page.
On cost, the HSE's Medicines Management Programme (MMP) names "best-value biological" medicines that clinicians are asked to prescribe first. In April 2026 it added Celltrion's tocilizumab biosimilar, Avtozma, to that list alongside Fresenius Kabi's Tyenne. The MMP report notes that, under the 2021 framework agreement with industry, a new biosimilar's price to the HSE can be no more than 55% of the originator's price as of 1 October 2021. HSE spending on tocilizumab fell from €19.6 million in 2023 to €13.9 million in 2024.
Keytruda is mainly given in hospital, so a biosimilar would affect hospital cancer budgets rather than the community High Tech Arrangement, where most best-value designations have been made so far. The HSE has not said how it would handle a pembrolizumab biosimilar. Our report on biosimilar savings and oncology uptake in Ireland covers that gap. No pembrolizumab biosimilar trial on ClinicalTrials.gov lists an Irish site.
Frequently Asked Questions
Does South Korea have no approved biosimilars?
No. Celltrion and Samsung Bioepis have many US and EU approvals. The "zero" figure covers only new US and EU approvals granted to Korean developers in 2026.
When could Keytruda biosimilars reach patients?
MSD says US biosimilar competition could begin in December 2028. EU timing depends on patents and supplementary protection certificates in each country and has not been confirmed by an official source.
Is Keytruda made in Ireland?
EMA product information lists MSD's Swords, Co Dublin site as a manufacturer of Keytruda's active substance. MSD has not disclosed the share of Keytruda produced in Ireland.
Outlook
Korea's quiet year may not last. Samsung Bioepis and Celltrion already have filings in the queue, and the next signals to watch are FDA acceptance of SB27, any EMA submissions for pembrolizumab biosimilars, and Celltrion's US and EU filings. For Ireland, the questions are how the HSE will buy hospital cancer biosimilars once they arrive, and what the change means for MSD's Irish biologics sites.
Sources
- US Food and Drug Administration, Biosimilar Product Information, content current as of 28 October 2026
- European Medicines Agency, Download medicine data (medicines report generated 2 November 2026)
- European Medicines Agency, Keytruda: EPAR and product information, Annex II, accessed 2 November 2026
- Merck & Co., Inc., Form 10-K for the year ended 31 December 2025, filed 24 February 2026
- HSE Medicines Management Programme, Best-value biological medicine: tocilizumab on the High Tech Arrangement, review of submission for Avtozma, 13 April 2026
- MSD Ireland, Our sites, accessed 2 November 2026
- ClinicalTrials.gov, studies NCT06348199, NCT06268613, NCT06939595, accessed 2 November 2026
- Chosunbiz, 17 Approvals for China and India vs. Zero for South Korea: K-Biotech Falls Behind in Biosimilar Race, Prepares Counterattack With Keytruda, 1 November 2026, as republished by Bytes Europe
- Biopharma APAC, 17 APAC-Made Biosimilars Approved in the US or EU in 2026, 28 October 2026
- Asia Economy, Samsung Bioepis Applies for Domestic Approval of Keytruda Biosimilar, 10 August 2026
- Asia Economy, Aiming for the 44 Trillion Won Market... Celltrion Applies for Approval of Keytruda Biosimilar, 24 August 2026
- Money Today (The Bio), report on Samsung Bioepis's US FDA application for SB27, 30 October 2026
- Indian Pharma Post, FDA accepts Zydus and Formycon's first-of-its-kind Keytruda Biosimilar for review, October 2026
Cover image: AI-generated illustration of the Keytruda vial and carton. It is not a photograph of the real product or its packaging.
