Korean pharmaceutical and biotech companies entering the EU: approvals, presence and market access

Why Europe, and why now

For Korean drugmakers Europe is the first large regulated market after Korea, and often the first in which a product proves itself internationally. Biosimilars led the way: Celltrion’s Remsima, the first monoclonal antibody biosimilar approved in Europe, and Samsung Bioepis’s portfolio of TNF-inhibitor, oncology and ophthalmology biosimilars. IQVIA data for the second quarter of 2025 show Celltrion’s Remsima line at 69% of European infliximab prescriptions, Yuflyma first among adalimumab biosimilars with 26% and Vegzelma first in bevacizumab with 24%; earlier IQVIA data put Celltrion and Samsung Bioepis together at 53.5% of Europe’s six largest biosimilar molecules. Novel medicines are following — Yuhan’s lazertinib, licensed to Johnson & Johnson, reached European patients as part of a combination therapy — and Korean contract manufacturers such as Samsung Biologics and SK bioscience supply European companies.

Europe is also changing. The EU’s first overhaul of its pharmaceutical legislation in twenty years reached political agreement in December 2025; joint EU health technology assessments began in January 2025; and the EU is pushing to secure supply of critical medicines. Korean companies entering now face both opportunity and new rules, and the ones that plan EU requirements into development — not after Korean approval — reach European patients years sooner.

Regulatory routes

Regulation (EC) No 726/2004 and Directive 2001/83/EC; timelines under current law.

Most Korean companies’ flagship products — biosimilars and new biologics — fall in the centralised procedure’s mandatory scope. The application is a full Common Technical Document; for a biosimilar, comparative quality, non-clinical and clinical data against the EU reference product; for a new active substance, the full development package, including a paediatric investigation plan agreed with EMA’s paediatric committee. Scientific advice (과학적 자문) from EMA before pivotal trials is worth seeking: European regulators may want different comparators, endpoints or populations from those MFDS or the FDA accepted. EU clinical trials run under the Clinical Trials Regulation through the CTIS portal, with one application for all member states involved.

Under the pharma package agreed in December 2025, the standard EMA assessment will fall to 180 days without clock-stop and the Commission decision to 46 days, once the new law applies after its transitional period — expected to be two to three years after adoption.

EU presence: what a Korean company must have

• Marketing authorisation holder (MAH). The applicant and holder must be established in the EU/EEA. A Korean company therefore needs an EU subsidiary, or a European partner that holds the authorisation.
• Qualified person for pharmacovigilance (QPPV). A named, qualified person residing and operating in the EU/EEA, responsible for the pharmacovigilance system, with a pharmacovigilance system master file and 24-hour availability.
• Manufacturing and import authorisation. An EU site holding a manufacturing/import authorisation must import the product from Korea.
• Qualified Person (QP). A QP at the EU importer certifies every batch before release to the EU market, after EU testing.
• Distribution and safety features. Wholesale distribution authorisations and good distribution practice in each market; for prescription medicines, the unique identifier and anti-tampering device under the falsified medicines rules.
• Local language and labelling. Product information and packaging in each country’s language, often with multi-country packs to manage stock.

These functions can be built in-house or bought from service providers — many Korean companies start with an EU subsidiary holding the authorisations and outsource QPPV, QP release and logistics to specialist firms, then insource as volumes grow and the portfolio broadens. The subsidiary’s location — the Netherlands, Ireland, Germany and Belgium are common — is chosen for regulatory talent, logistics, tax and language, not for the authorisation itself, which is EU-wide.

GMP, inspections and import testing

Korean manufacturing sites making medicines for the EU must comply with EU GMP and are inspected by an EU authority, usually the national agency of the importer’s or MAH’s member state, coordinated by EMA. Korea has been a member of PIC/S, the international GMP inspectorates’ scheme, since 2014, which helps, but it does not replace EU inspection.

The EU has mutual recognition agreements on GMP with countries such as the United States, Japan, Canada, Switzerland, Australia, New Zealand and Israel, which allow batch testing to be waived. There is no such agreement with Korea. Each batch of a finished medicine made in Korea must therefore be re-tested in the EU and certified by a QP before release — a cost and a lead time to plan for, and a reason some Korean companies use EU contract manufacturers for packaging and release.

For active pharmaceutical ingredients the position is better. Since a Commission implementing decision of 2019, following audits in 2016 and 2018, Korea is on the EU list of third countries whose regulatory framework for APIs is equivalent to the EU’s. Korean API makers supplying EU manufacturers therefore need no written confirmation from MFDS for each shipment, unlike suppliers from countries not on the list. EU customers still audit the site and reference it in their dossiers.

Korea’s APIs enter Europe as equals. Korea’s finished products still stop at the EU border for a Qualified Person’s signature.

Voixa Korea

Data protection and the new EU law

Under current law, an innovative medicine gets eight years of regulatory data protection and ten years of market protection, extendable to eleven — the ‘8+2+1’ rule — during which generics and biosimilars cannot rely on its data or be marketed. Orphan medicines get ten years of market exclusivity. Biosimilar developers time their EU filings and launches around these dates.

The pharma package agreed by the Council and Parliament on 11 December 2025 replaces this with ‘8+1+1+1’: eight years of data protection and one of market protection as a baseline, with up to two further one-year extensions for products meeting conditions such as unmet medical need or early EU launch, keeping the maximum at eleven years. Orphan exclusivity becomes nine years, extendable to eleven for diseases without treatment. The Bolar exemption is broadened to cover regulatory, HTA, pricing and tender submissions, which helps biosimilar and generic companies prepare launches before expiry. A transferable exclusivity voucher rewards priority antimicrobials. The texts must still be formally adopted and will apply after a transitional period; until then, current rules govern.

HTA, pricing and reimbursement

An EU authorisation lets a product be sold; it does not get it paid for. Pricing and reimbursement remain national, and every member state has its own system: AMNOG benefit assessment in Germany, HAS and CEPS in France, AIFA in Italy, regional and hospital tenders in Spain, Italy and the Nordic countries. Biosimilars compete largely through tenders and hospital formularies, where price, supply reliability and service decide; novel medicines need clinical and economic evidence for each payer.

The HTA Regulation (EU HTA 규정) — Regulation (EU) 2021/2282 — adds a joint clinical assessment at EU level: from 12 January 2025 for new cancer medicines and advanced therapies, from 2028 for orphan medicines and from 2030 for all new active substances in the centralised procedure. The joint assessment compares the product with relevant alternatives in the populations national payers care about; national bodies still decide price and reimbursement, but must take the joint report into account. For a Korean company planning a pivotal trial, the comparator and endpoints that EU payers expect now need to be designed in from the start, through joint scientific consultation where possible.

The EU–Korea FTA (한-EU FTA) eliminates tariffs on pharmaceuticals and includes an annex on medicines and medical devices requiring transparency and procedural fairness in pricing and reimbursement decisions. It does not harmonise prices or guarantee listing.

Medical devices, combination products and digital health

Many Korean life-science companies sell devices as well as medicines. Medical devices follow a different EU regime: the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746, with conformity assessment by notified bodies rather than EMA, CE marking, an EU authorised representative for non-EU manufacturers, and registration in EUDAMED. Notified-body capacity and the transition deadlines extended by the EU make early planning essential. Drug–device combinations — prefilled syringes and autoinjectors for biosimilars, for example — need the device part assessed and documented in the medicine’s dossier. AI-based software as a medical device also falls under the EU AI Act’s high-risk rules on top of the device regulation.

Supply chain and security of supply

Europe has learned from shortages, and buyers now ask about supply resilience as much as price. Tenders increasingly score continuity of supply and penalise stock-outs; the EU’s critical medicines initiative aims to diversify and strengthen production of essential medicines, with preference for supply chains that reduce dependence on single sources. Korean manufacturers can present themselves as a reliable, high-quality alternative to concentrated Asian supply — but need European stock, EU release capacity and contingency plans to make the case. Serialisation data must flow into the European Medicines Verification System for prescription products, and cold-chain logistics for biologics must meet good distribution practice in every country.

Business models: own subsidiary or partner

Simplified; models change as portfolios grow.

Samsung Bioepis has sold ten products in Europe since 2016, commercialising some itself and most through partners; Celltrion has moved progressively to direct sales, which it credits for winning share even when launching later than competitors. Smaller Korean companies usually start with partners and keep the option to build their own presence once they have two or three products in the same therapeutic area.

Structure, tax and the Korean side

On the Korean side, capital sent to an EU subsidiary is an overseas direct investment (해외직접투자, haeoe jikjeop tuja) reported to a Korean foreign exchange bank before remittance under the Foreign Exchange Transactions Act. Supply of products from Korea to the EU subsidiary, royalties for IP and service charges must be priced at arm’s length in both Korea and the EU member state; a distributor subsidiary is expected to earn a routine margin, while an EU entity that also holds authorisations and runs pharmacovigilance and market access performs more functions and needs a matching return. Dividends from an EU subsidiary held at 10% or more are 95% excluded from Korean corporate tax under Article 18-4 of the Corporate Tax Act; withholding in the EU state depends on the treaty — 5% in some, 10% or 15% in others. Large groups also apply the global minimum tax.

Korean public support includes the Korea Health Industry Development Institute’s overseas programmes, KOTRA’s European trade centres, and K-SURE and Korea Eximbank for export credit and investment financing.

A worked example

A Korean biotech company has an MFDS-approved biosimilar of a monoclonal antibody whose EU protection expires in three years. It chooses the centralised procedure, seeks EMA scientific advice on its comparative clinical study, and forms a Dutch subsidiary as marketing authorisation holder. A specialist firm provides the QPPV and pharmacovigilance services; a Belgian contract manufacturer holds the import authorisation, performs EU batch testing and provides QP release. The Korean plant passes an EU GMP inspection a year before approval.

Commercially, the company licenses Germany, France and the Nordics to a European partner with tender expertise, and keeps the Netherlands and Belgium for its own small team. It files its tender documents before the reference product’s protection expires under the broadened Bolar exemption, and launches on day one. On the Korean side, it reports the investment in the Dutch subsidiary, sets transfer prices for supplies and services, and plans dividends under the Korea–Netherlands treaty and Korea’s foreign dividend exclusion.

Mistakes we see

1. Assuming MFDS or FDA data packages are enough without EMA scientific advice.
2. No EU entity ready when the authorisation is due.
3. Underestimating import testing and QP release for Korean-made batches.
4. Ignoring HTA in pivotal trial design.
5. Treating the EU as one market for pricing, tenders and languages.
6. Partner contracts without exit clauses for authorisations and data.
7. Planning around the new data protection rules before they apply.

Terms you will meet

Questions readers ask

About the author

Alexander Baranov

Founder of the BCA Group · cross-border corporate and tax adviser since 2008

Alexander advises foreign founders and groups on company formation, tax structuring and corporate law in more than 40 jurisdictions across Europe, the Gulf, Asia and Latin America. He is the author of nine books on international business and tax and writes regularly for professional finance and tax journals. He works in English, German, Spanish and Russian.

This guide is based on the Korean statutes cited in the text and on our own filings. It is reviewed when the law or official rates change.

Ask Alexander on WhatsAppContact