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Biologics and Biosimilar Regulations and Registration in South Korea

  • The Korean pharmaceutical market is estimated to be worth $24.3 billion in 2019, and between 2015 and 2019, it grew at a compound annual growth rate (CAGR) of 5.0%.

  • The export volume has been growing with a CAGR of 15% with K-pharma actively establishing itself on the international market.

  • By keeping prices low and relying more on biosimilar drugs, which have lower research costs than innovative biologics, Korea believes that can successfully capture a larger share of the biosimilar market.

Biologic Biosimilar Regulation Registration South Korea

This article outlines Biologics and Biosimilar Regulations and Registration in South Korea (MFDS)

In South Korea, the regulation and registration of biologics and biosimilars falls under the oversight of the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). The MFDS establishes and enforces regulations to ensure the safety, efficacy, and quality of biologic products, including biosimilars.

Korea's three-tiered regulatory structure for biosimilar products is as follows: Pharmaceutical Affairs Act; Notification of the regulation on biological product review and authorization; and Guidelines for the assessment of biosimilar goods.

Biologics are complex therapeutic substances produced using living organisms or their components, such as cells, proteins, nucleic acids, or tissues. They are used to prevent, treat, diagnose, or alleviate various medical conditions, including chronic diseases and rare disorders. Biologics can include monoclonal antibodies, vaccines, gene therapies, and other advanced therapeutic products.

Biosimilars are biological products that are highly similar to an already approved reference biologic (also known as the originator or reference product). They demonstrate similarity in terms of quality, safety, and efficacy based on a comprehensive comparability assessment. Biosimilars are not considered identical to the reference product due to the inherent variability of biological materials and manufacturing processes.

Patentability: For all pharmaceutical products, including conventional "small molecules" and biologics, Korea is currently enforcing a patent linkage system under the Korea-U.S. Free Trade Agreement, which was passed in 2011 and became effective on March 15, 2012. Similar to the U.S. Hatch-Waxman Act, the Korean patent linkage system creates a legislative framework that aims to strike a balance between incentives for continuous innovation by innovator businesses and chances for generic pharmaceuticals to enter the market.

Clinical Trial Requirements:


  • Clinical trials for biosimilars in South Korea focus on demonstrating the similarity between the biosimilar and the reference biologic.

  • Comparative clinical studies are typically conducted to assess the safety and efficacy of the biosimilar compared to the reference product. These studies aim to establish equivalence or non-inferiority.

  • Trials may include pharmacokinetic (PK) and pharmacodynamic (PD) studies to assess the similarity in drug exposure and effects.

  • Immunogenicity studies are conducted to assess the potential for immune responses to the biosimilar.

Biologics (Innovative Products):

  • Clinical trials for innovative biologics in South Korea are more extensive and follow the traditional drug development pathway.

  • Phase 1 trials focus on safety and dose-ranging, often involving a small number of healthy volunteers.

  • Phase 2 trials involve a larger number of patients to assess the drug's efficacy and optimal dosing.

  • Phase 3 trials are larger, randomized, controlled trials that further evaluate efficacy and safety across diverse patient populations.

  • Post-marketing studies (Phase 4 trials) may be required to monitor long-term safety and gather additional data.

Comparability Studies:

  • For biosimilars, comparability studies are essential to demonstrate similarity to the reference product. These studies encompass a range of analytical, functional, and biological assays to establish similarities in quality attributes, such as structure, purity, and potency.

Extrapolation of Indications:

  • South Korea allows for the extrapolation of indications for biosimilars based on scientific justification. This means that if a biosimilar is approved for one indication, it may be approved for other indications of the reference product without conducting separate clinical trials.

Important Documents:

Application Form: A completed application form provided by the regulatory authority.

Quality Documentation:

  • Drug substance and drug product information, including manufacturing process details, quality control methods, and specifications.

  • Description of the facilities where the product is manufactured, tested, and stored.

  • Information on stability studies to demonstrate the product's shelf life.

Non-Clinical Data:

  • Non-clinical studies to assess the safety, pharmacology, and toxicology of the product.

  • Data on animal studies, if applicable, to demonstrate the product's safety profile.

Clinical Data:

  • Clinical trial data, including protocols, investigator brochures, informed consent forms, and clinical study reports.

  • Data on pharmacokinetics, pharmacodynamics, safety, and efficacy.

  • Comparative clinical studies and data for biosimilars to demonstrate similarity to the reference product.

Analytical Data:

  • Comparative analytical studies to establish the similarity of the biosimilar to the reference product.

  • Details of the analytical methods used for assessing quality attributes.

Immunogenicity Data:

  • Immunogenicity data to evaluate the potential for immune responses to the product.

  • Information on antibody formation and impact on safety and efficacy.

Risk Management Plan:

  • A risk management plan outlining strategies to monitor and manage potential risks associated with the product.

Labeling and Package Insert:

  • Drafts of the product labeling, package insert, and patient information leaflet.

  • Details on how the product should be used, dosing instructions, contraindications, and precautions.

Pharmacovigilance Plan:

  • A plan for monitoring and reporting adverse events and safety data post-approval.

Environmental Risk Assessment (if applicable):

  • Information on potential environmental risks associated with the product and its manufacturing process.

Other Supporting Documentation:

  • Documentation demonstrating compliance with Good Manufacturing Practice (GMP) guidelines.

  • Regulatory approvals from other countries, if applicable.

  • Any additional documents required by the regulatory authority.

Regulatory Process:

Regulatory Submission:

  • Once clinical and analytical data are collected, a comprehensive regulatory submission is prepared.

  • The submission includes data on quality, safety, efficacy, and comparability.

Regulatory Review:

  • The MFDS conducts a thorough review of the submitted data to assess the product's quality, safety, and efficacy.

  • For biosimilars, the focus is on demonstrating similarity to the reference product.

Approval Decision:

  • Based on the review, the MFDS makes an approval decision.

  • If the product meets the necessary standards, it receives regulatory approval for marketing and distribution.

Timelines: The review period varies from 90 days to 120 days.

Post-marketing surveillance for biosimilars and biologics in South Korea:

Reporting Adverse Events:

  • Healthcare professionals, patients, and other stakeholders are encouraged to report any adverse events, side effects, or unexpected reactions related to biologics and biosimilars to the MFDS.

  • Manufacturers are also required to submit periodic safety update reports (PSURs) to the MFDS.

Pharmacovigilance System:

  • Manufacturers of biologics and biosimilars are expected to establish and maintain pharmacovigilance systems to actively monitor and assess the safety of their products.

  • This includes continuous surveillance of adverse events, collection of safety data, and timely reporting to regulatory authorities.

Signal Detection:

  • Regulatory authorities use signal detection techniques to identify potential safety concerns by analyzing large volumes of safety data.

  • This helps to identify any emerging safety issues that may not have been apparent during the pre-market clinical trials.

Risk Management Plans:

  • Manufacturers may be required to develop risk management plans to mitigate known and potential risks associated with their products.

  • These plans outline strategies for minimizing risks and ensuring that the benefits of the product outweigh the risks.

Communication and Transparency:

  • Regulatory authorities maintain open communication with healthcare professionals, patients, and the public regarding safety information, regulatory actions, and updates related to biologics and biosimilars.

Collaboration with Global Regulatory Authorities:

  • Regulatory authorities often collaborate with other global regulatory agencies to share safety information and coordinate actions when needed.

Post-Market Studies:

  • In some cases, regulatory authorities may require manufacturers to conduct post-market studies to gather additional safety or efficacy data in real-world settings.

Recall and Safety Alerts:

  • If serious safety concerns arise, regulatory authorities can initiate product recalls or issue safety alerts to protect patients and the public.



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