January 22, 2026

South Korea has rapidly positioned itself as a global hub for biologics and biosimilars development, supported by a strong regulatory framework, advanced manufacturing infrastructure, and cost-efficient biosimilar pathways. With increasing demand for monoclonal antibodies, recombinant proteins, vaccines, and advanced biologic therapies, understanding MFDS biologics and biosimilars regulations is critical for successful market entry.

According to industry data, Korea’s pharmaceutical market exceeded USD 24 billion, with biologics and biosimilars forming one of the fastest-growing segments. The country’s strategic focus on biosimilar adoption, patent linkage enforcement, and export-driven growth has made MFDS approval a key milestone for global biologics manufacturers.

This in-depth guide by Maven Regulatory Solutions explains the regulatory framework, clinical trial requirements, registration process, documentation, post-marketing surveillance, and compliance expectations for biologics and biosimilars in South Korea using professional yet practical language aligned with global regulatory standards.

South Korea Biologics & Biosimilars Regulatory Authority (MFDS)

The Ministry of Food and Drug Safety (MFDS) is the national authority responsible for regulating biological medicinal products and biosimilars in South Korea. Formerly known as KFDA, MFDS ensures that all biologics entering the Korean market meet strict quality, safety, and efficacy standards.

MFDS operates in coordination with the National Institute of Food and Drug Safety Evaluation (NIFDS), which conducts scientific reviews of comparability studies, clinical data, and manufacturing controls.

Key MFDS Regulations Governing Biologics & Biosimilars

South Korea follows a three-tiered regulatory structure for biologics and biosimilars:

  1. Pharmaceutical Affairs Act
  2. Regulation on Biological Product Review & Authorization
  3. MFDS Guidelines for Biosimilar Evaluation

These regulations are aligned with ICH, WHO, EMA, and FDA biosimilar principles, while maintaining Korea-specific requirements.

What Are Biologics and Biosimilars? (MFDS Perspective)

Biologics are complex medicinal products derived from living systems, including:

  • Monoclonal antibodies
  • Vaccines
  • Recombinant proteins
  • Gene and cell-based therapies

They are used to treat chronic diseases, autoimmune disorders, oncology, and rare conditions.

Biosimilars

Biosimilars are highly similar versions of an already approved reference biologic, demonstrating no clinically meaningful differences in:

  • Quality
  • Safety
  • Efficacy

Due to the inherent variability of biological systems, biosimilars are not identical but must meet stringent comparability standards.

Patent Linkage System in South Korea

South Korea enforces a patent linkage system under the Korea–U.S. Free Trade Agreement (KORUS FTA).

Key Features

  • Innovator patents are listed and linked to marketing approval
  • Biosimilar applicants must address patent status before approval
  • Designed to balance innovation protection and biosimilar market entry

This system is comparable to the Hatch-Waxman framework but adapted for biologics and biosimilars.

Clinical Trial Requirements for Biologics & Biosimilars (MFDS)

Study Type

Purpose

Comparative PK/PD

Demonstrate exposure similarity

Comparative Clinical Trials

Confirm equivalent or non-inferior efficacy

Immunogenicity Studies

Assessing immune response risk

Extrapolation Studies

Support approval for multiple indications

MFDS allows extrapolation of indications when scientific justification is robust.

Innovative Biologics Clinical Development

Phase

Focus

Phase I

Safety & dose-finding

Phase II

Efficacy & optimal dosing

Phase III

Large-scale safety & efficacy

Phase IV

Post-marketing surveillance

MFDS Registration Documents for Biosimilars & Biologics

Category

Key Documents

Quality

Manufacturing process, control strategy, stability

Non-Clinical

Pharmacology & toxicology data

Clinical

PK/PD, efficacy, safety studies

Analytical

Structural & functional comparability

Immunogenicity

Antibody response evaluation

RMP

Risk management plan

PV Plan

Pharmacovigilance system

GMP

Facility compliance evidence

Labeling

Korean packages insert & patient leaflet

MFDS Registration Process for Biologics & Biosimilars

Regulatory Pathway

  1. Pre-Submission Planning
  2. Dossier Compilation (CTD format)
  3. MFDS/NIFDS Scientific Review
  4. Supplementary Data Requests (if needed)
  5. Marketing Authorization Approval
  6. Post-Approval Commitments

Indicative Review Timeline

  • 90 to 120 days, depending on complexity and data completeness

Post-Marketing Surveillance & Pharmacovigilance

MFDS maintains a robust pharmacovigilance ecosystem for biologics and biosimilars.

Key Elements

  • Mandatory adverse event reporting
  • Periodic Safety Update Reports (PSURs)
  • Signal detection & risk evaluation
  • Post-market studies (if required)
  • Product recalls & safety alerts

Manufacturers must maintain continuous safety monitoring systems and communicate transparently with MFDS.

Why MFDS Compliance Is Critical

Non-compliance may result in:

  • Approval of suspension or withdrawal
  • Mandatory recalls
  • Regulatory penalties
  • Loss of market trust

How Maven Regulatory Solutions Supports Biologics & Biosimilars

Maven Regulatory Solutions offers end-to-end MFDS regulatory consulting, including:

  • Biosimilar regulatory strategy
  • Comparability & extrapolation planning
  • MFDS dossier preparation
  • Clinical trial & IND support
  • GMP readiness & inspections
  • Pharmacovigilance & lifecycle management

Frequently Asked Questions (FAQs)

Q1. Does MFDS allow indication extrapolation for biosimilars?
Yes, with strong scientific justification.

Q2. Are local clinical trials mandatory?
Not always; MFDS may accept global data with justification.

Q3. How long does MFDS biosimilar approval take?
Typically 90–120 days after complete submission.

Q4. Are post-marketing studies mandatory?
They may be required based on risk profile.