Korea eases biosimilar review rules, allowing frozen reference drugs

South Korea's food and drug safety ministry said it revised its guideline for evaluating biosimilars, allowing frozen reference products to be used in quality comparisons and waiving some trial data requirements, as it moves to align domestic reviews with global regulatory practice.

The revision, issued by the ministry's National Institute of Food and Drug Safety Evaluation, took effect the same day. It follows a July amendment to the rules governing approvals of biological products, which removed the obligation to submit Phase 3 therapeutic confirmatory clinical trial data when quality, non-clinical and pharmacokinetic comparability have been demonstrated. The new guideline sets out the detailed data requirements under that change.

A reference product that has been stored frozen may be used in analysis once its quality has been confirmed, addressing a long-standing difficulty companies faced in securing comparator drugs. The guideline also relaxes the previous principle that a biosimilar be analyzed simultaneously alongside its reference product: where precise analytical methods are used, results already obtained from a reference product can serve as the basis for comparison.

It set minimum batch numbers for the quality assessment at 10 batches of the reference product and six of the test product, and specified where animal and human testing can be trimmed. Repeated-dose toxicity study data are waived when quality and pharmacological comparability have been demonstrated, and Phase 3 data are waived when quality plus non-clinical and pharmacokinetic comparability are established.

The guideline was produced as part of the ministry's broader "60 food and drug safety tasks" program, which it describes as a drive to present internationally harmonized evaluation methods so that Korean companies can develop biosimilars more quickly and efficiently. The ministry said it expects the harmonized standards to shorten development times and costs and to support growth in the domestic biosimilar industry.

"Based on regulatory science expertise, we will continue to pursue harmonization with global review standards and spare no reasonable regulatory support so that domestic biopharmaceuticals can be commercialized quickly," the ministry said in a statement.