South Korea is the world's second-largest source of FDA-approved biosimilars by manufacturer headquarters — behind only the United States itself. Companies headquartered in South Korea, led by Celltrion and Samsung Bioepis, have developed and gained US approval for more than a dozen biosimilars spanning infliximab, trastuzumab, adalimumab, ustekinumab, aflibercept, eculizumab, denosumab, and ranibizumab. In 2025 alone, Celltrion launched Steqeyma (ustekinumab-stba) and Avtozma (tocilizumab-anoh) in the US, while Samsung Bioepis brought Pyzchiva (ustekinumab-ttwe) to market.
Now the regulatory infrastructure behind that pipeline is being overhauled. In 2026, the Ministry of Food and Drug Safety (MFDS) is rolling out a sweeping set of reforms designed to accelerate biosimilar approvals, modernize the CDMO regulatory framework, and introduce AI-assisted drug review. For US launch teams that source biosimilar manufacturing capacity from Korean CDMOs, or that compete against Korean-developed biosimilars in the US market, these changes are operationally relevant.
This article maps the key MFDS reforms, explains how they affect the global biosimilar supply chain, and identifies what US regulatory and commercial teams should monitor. It is independent information and not regulatory advice for a specific product.
The scale of South Korea's biosimilar footprint
Understanding why MFDS reform matters requires appreciating the scale of Korean biosimilar activity:
- Domestic approvals: Over 70 biosimilars have been approved by MFDS as of 2024, with 18 approvals recorded in that year alone — the highest annual total to date
- Global pipeline: According to GlobalData's Pharmaceutical Intelligence Center, 24 biosimilars developed by Korean firms are approved across international markets, including 11 monoclonal antibodies, with another five in pre-registration across 10 therapy areas
- Market size: South Korea's biopharmaceutical market is approximately $22 billion, making it the 13th-largest pharmaceutical market globally
- US approvals: Celltrion and Samsung Bioepis together hold more than 15 FDA-approved biosimilars, making South Korea the leading non-US source of biosimilar products in the American market
The Korean biosimilar model was built on a deliberate strategy: harmonize domestic regulatory requirements with the WHO, EMA, and FDA frameworks so that a product meeting MFDS standards could simultaneously satisfy export-market requirements. This integration of regulatory compliance with commercial market access is the operational core of the Korean biosimilar industry.
Key MFDS reforms in 2026
1. Streamlined biosimilar review pathway
The most consequential reform is a dedicated fast-track review program for biosimilars, beginning in 2026. Key elements:
| Reform element | Before | After (2026) |
|---|---|---|
| Total review time | ~420 days (median) | Target: 295 days |
| Review structure | General review teams | Product-specific review teams |
| GMP/GCP inspections | Standard scheduling | Expedited scheduling |
| Pre-submission consultations | Limited | Expanded direct consultations |
| Long-term goal | N/A | Approval within 240 days for new biologics and biosimilars |
The review-time reduction from approximately 420 days to 295 days is achievable in part because Korean biosimilar developers filing with MFDS typically also hold EMA or FDA approval. This gives MFDS access to high-quality precedent data packages, reducing the agency's independent analytical burden.
MFDS is also rationalizing clinical trial requirements for biosimilars through a Public-Private Consultative Body for Biosimilar Clinical Improvement, which has been operating since 2025 and is developing a pre-review procedure manual and updated evaluation guidelines.
2. CDMO regulatory framework
The Special Act on Regulatory Support for Contract Development and Manufacturing Organizations for Biopharmaceuticals was promulgated in late 2025 and is being implemented by the end of 2026. This is South Korea's first dedicated legal framework for export-oriented biopharmaceutical CDMOs. Key provisions:
- New registration system: A formal registration system for export-oriented biopharmaceutical manufacturing — previously absent from the Pharmaceutical Affairs Act
- Tailored facility standards: Facility standards designed specifically for export-focused biopharmaceutical manufacturing
- GMP compliance certification: Institutionalized GMP compliance certification for CDMO sites
- API certification: Active pharmaceutical ingredient certification for CDMO manufacturing sites
On March 24, 2026, Celltrion committed 1.2 trillion won ($805 million) to expand its Incheon facility, alongside scaling its US manufacturing site, targeting total capacity of 570,000 liters per year. On March 10, 2026, Samsung Biologics partnered with Eli Lilly to establish a new Gateway Labs site in Korea. These investments reflect confidence that the new regulatory framework will support faster scaling and more reliable export qualification.
3. AI-assisted drug review
MFDS is implementing the use of artificial intelligence and data analysis in both drug reviews and post-marketing surveillance. The agency plans to start utilizing AI for regulatory evaluation tasks in 2026, beginning with repetitive work such as collecting and organizing review materials. MFDS anticipates that AI use will expand to other areas as more structured regulatory data becomes available.
The National Institute for Food and Drug Safety Evaluation (NIFDS) is leading the AI implementation effort, while other MFDS divisions are exploring big data methodologies for evaluating risks associated with overseas GMP inspections.
4. Enhanced equivalence test standards
A draft revision of pharmaceutical equivalence test standards introduces new requirements for generics and biosimilars:
- Stricter documentation requirements aligned with international standards
- Updated bioequivalence strategy guidelines
- Revised supporting data package requirements prior to submission
These changes may require companies to reassess bioequivalence strategies before filing with MFDS.
5. International regulatory harmonization and joint reviews
MFDS is expanding joint review arrangements with the EMA and PMDA, enabling:
- Parallel submissions across multiple agencies
- Shared inspection results and reliance on trusted regulatory authorities
- Faster cross-border market entry for innovative medicines
This harmonization directly benefits Korean biosimilar developers who file simultaneously in the US, EU, Japan, and domestic markets — and benefits the global supply chain by reducing duplicative regulatory work.
The Songdo manufacturing cluster
The geographic concentration of biomanufacturing capacity in Songdo, Incheon — a purpose-built biotechnology city — is strategically significant. Songdo now houses the single largest concentration of biopharmaceutical manufacturing capacity at a single location in the world, combining Samsung Biologics' four production facilities, Celltrion's dedicated manufacturing complex, and CDMO operations that serve both domestic companies and global clients. This geographic concentration enables shared infrastructure, labor pool depth, and supply chain efficiency that generates durable cost advantages.
Supreme Court patent safe harbor
In a landmark 2025 ruling, the South Korean Supreme Court clarified that manufacturing biosimilar products in Korea for export to clinical trial sites abroad does not constitute patent infringement. This ruling is operationally important for the CDMO sector: foreign biotechs can now contract Korean manufacturers for clinical supply chains without fear of patent litigation. The ruling removes a major barrier to entry for foreign clients and reinforces Korea's position as a safe harbor for manufacturing related to legitimate clinical purposes.
The Celltrion and Samsung Bioepis pipeline effect
The MFDS reforms come at a moment when Korean biosimilar developers are targeting the next wave of patent expirations:
Celltrion
| Product | Reference | Status / Target |
|---|---|---|
| CT-P44 | Darzalex (daratumumab) IV and SC | Late-stage biosimilar development for multiple myeloma |
| Omlyclo (omalizumab-igec) | Xolair | FDA approved March 2025; US launch expected September 2026 |
| Eydenzelt (aflibercept-boav) | Eylea | FDA approved October 2025 |
| Steqeyma (ustekinumab-stba) | Stelara | Launched March 2025 in US |
| Avtozma (tocilizumab-anoh) | Actemra | Launched October 2025 in US |
Samsung Bioepis
| Product | Reference | Status |
|---|---|---|
| Pyzchiva (ustekinumab-ttwe) | Stelara | Launched February 2025 in US |
| Ospomyv (denosumab-dssb) | Prolia | FDA approved February 2025 |
| Xbryk (denosumab-dssb) | Xgeva | FDA approved February 2025 |
| Opuviz (aflibercept-yszy) | Eylea | FDA approved May 2024; launch delayed to 2026 |
| Epysqli (eculizumab-aagh) | Soliris | FDA approved |
Samsung Bioepis has also announced a new slate of early-stage biosimilar candidates, and both companies continue to expand manufacturing capacity at scale.
The next major patent cliff targets Dupixent (dupilumab), with over $14 billion in annual sales and patent protection extending to approximately 2031. Korean companies including Chong Kun Dang, Daewoong, and Kyungdong are already positioning themselves as early entrants in the IL-4/IL-13 pathway biosimilar space.
What US launch teams should do
For teams competing against Korean biosimilars
Track MFDS reform implementation. Faster Korean domestic approvals translate to faster global filing timelines. When Celltrion or Samsung Bioepis gets MFDS approval sooner, their EMA and FDA follow-on filings benefit from the momentum and data maturity.
Monitor the CDMO framework. The new Special Act creates a more predictable, certifiable manufacturing environment for Korean CDMOs. US companies using Korean CDMO capacity — or competing against products manufactured there — should understand how the new GMP certification system affects supply chain reliability.
Watch the daratumumab and dupilumab timelines. The next generation of Korean biosimilar targets will affect US formulary dynamics. Daratumumab biosimilars alone could reshape multiple myeloma treatment economics.
For teams using Korean CDMO capacity
Evaluate the new GMP certification. The institutionalized GMP compliance certification under the CDMO Special Act may simplify FDA cross-reference and inspection alignment for US-bound products.
Leverage parallel review opportunities. MFDS's expanded joint review arrangements with EMA and PMDA create opportunities for simultaneous multi-market filings when using Korean manufacturing sites.
Assess AI-assisted review implications. MFDS's adoption of AI in the review process may accelerate approval timelines, but it also raises questions about how AI-generated assessments interact with FDA's own evaluation of products manufactured in Korea.
The broader competitive context
South Korean biosimilar firms are no longer niche players. According to market analyses, Celltrion and Samsung Bioepis together control more than 53% of market share in major biosimilar classes (infliximab, etanercept, adalimumab) in Europe. In the US, Humira biosimilars now hold approximately 20% of total adalimumab market share, up sharply from 2.2% in early 2024, with Korean-manufactured products among the leading competitors.
The global biosimilar market is projected to grow from $36 billion in 2024 to $114 billion by 2031. The Asia-Pacific region, led by Korea and India, drives the fastest regional growth. Europe remains the largest regional market at approximately 38% of global share, but leadership in biosimilar development and manufacturing has clearly shifted toward Asia-based suppliers.
For regulatory professionals who need to understand the full scope of Korean pharmaceutical and medical device market entry — including MFDS registration requirements for both drug and device products — KoreaMedGuide publishes regulatory and market-access guidance for South Korea's healthcare market, covering MFDS drug and device registration, Korea market-entry strategy, and compliance pathways.
What to monitor next
- MFDS streamlined review pathway implementation. Watch for the first biosimilar approvals processed under the new 295-day timeline to assess whether the reform delivers on its promise.
- CDMO Special Act subordinate regulations. The detailed implementing regulations and supporting computerized systems are still being developed. These will define the practical operation of the new GMP certification regime.
- Daratumumab biosimilar pipeline. Celltrion's CT-P44 targeting both IV and SC formulations of daratumumab would be a major competitive event in the multiple myeloma market.
- Dupilumab biosimilar positioning. Korean companies preparing for the Dupixent patent cliff represent the next wave of IL-4/IL-13 pathway competition.
- AI-assisted review outcomes. The quality and consistency of AI-assisted regulatory evaluations will determine whether this innovation accelerates or complicates cross-border regulatory reliance.
- Korean biosimilar pricing dynamics. Stelara biosimilars entered the US market with 85% discounts in 2025. Watch whether the daratumumab and dupilumab biosimilar classes follow similar pricing strategies.
- US-Korea regulatory alignment. BIOSECURE Act implementation and broader US-China supply chain de-risking may increase the strategic value of Korean manufacturing capacity, making MFDS reforms even more consequential for US market access.
Sources
- BioSpectrum Asia. "South Korea's Biosimilar Boom Enters High-Stakes 'Third Wave.'" 2026. https://www.biospectrumasia.com/analysis/25/27438/south-koreas-biosimilar-boom-enters-high-stakes-third-wave.html
- Freyr Solutions. "South Korea Pharmaceutical Regulatory Updates 2026: 3 Key Changes Impacting Market Entry." 2026. https://www.freyrsolutions.com/blog/south-korea-pharmaceutical-regulatory-updates-2026-3-key-changes-impacting-market-entry
- Pacific Bridge Medical. "Korea Pharmaceutical Update: Registration Policy and Regulatory Changes." January 2026. https://www.pacificbridgemedical.com/publication/korea-pharmaceutical-update-registration-policy-and-regulatory-changes
- Korea Biomedical Review. "MFDS Readies New Regulatory Regime to Propel Bio-CDMO Global Expansion." 2026. https://www.koreabiomed.com/news/articleView.html?idxno=30171
- Drug Patent Watch. "Asia's Biosimilar Market: Japan, South Korea & Malaysia." 2026. https://www.drugpatentwatch.com/blog/biosimilars-in-developed-and-developing-east-and-southeast-asian-countries-japan-south-korea-and-malaysia-overview-evolution-and-regulations-assessment
- GaBI Online. "Regulations for Biosimilars in South Korea." https://gabionline.net/es/directrices/Regulations-for-biosimilars-in-South-Korea
- GaBI Journal. "Korean Regulations for Biosimilars." https://gabi-journal.net/korean-regulations-for-biosimilars.html
- Samsung Bioepis. "Biosimilar Market Report, 12th Edition, Q1 2026." https://biologicshq.com/wp-content/uploads/2026/02/SB-Biosimilar-Market-Report-Q1-2026.pdf
- Biosimilars Review & Report. "US Biosimilar Filings and Approvals." Updated 2026. https://biosimilarsrr.com/us-biosimilar-filings
- GaBI Online. "Biosimilars Approved in the US." Updated January 27, 2026. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
- Biosimilar IP. "How the US Compares to Europe on Biosimilar Approvals." January 22, 2026. https://www.biosimilarsip.com/2026/01/22/how-the-u-s-compares-to-europe-on-biosimilar-approvals-and-products-in-the-pipeline-updated-january-22-2026
- Artixio. "Biologics and Biosimilar Regulations and Registration in South Korea." February 2026. https://www.artixio.com/post/biologics-and-biosimilar-regulations-and-registration-in-south-korea
- FDA. "Approved Biosimilar Products." Updated 2026. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
- Chambers and Partners. "Life Sciences & Pharma IP Litigation 2026 — South Korea: Trends and Developments." https://practiceguides.chambers.com/practice-guides/life-sciences-pharma-ip-litigation-2026/south-korea/trends-and-developments
