The Ministery of Food and Drug Safety will ease regulations needed to develop biosimilars (biosimilar). If certain requirements are met, phase 3 clinical trial data and some animal study data may be omitted, with the aim of cutting development time and expense.
The Ministery of Food and Drug Safety said on Jul. 14 it will revise and implement the Regulation on Approval and Review of Biological Products.
The revision was prepared as a follow-up to the president-led bio-innovation forum in September last year. The Ministery of Food and Drug Safety said it prepared the amendment while running a public-private consultative body to improve biosimilar clinical trials with the industry.
Until now, to obtain approval for a biosimilar, companies had to submit both phase 1 and phase 3 clinical trial data to prove that its quality and efficacy are equivalent to the original drug.
Going forward, if equivalence with the original drug is sufficiently confirmed through quality and preclinical results and pharmacokinetic (PK) comparisons, phase 3 clinical trial data will not be required. However, if equivalence is hard to determine based on comparisons alone, a phase 3 clinical trial will be needed as before.
Regulations on preclinical animal testing will also be eased. If equivalence is demonstrated through quality and pharmacological comparisons, repeated-dose toxicity study data will not be required. A repeated-dose toxicity study is a test that administers a test substance to animals multiple times to check for toxicity.
The Ministery of Food and Drug Safety said this measure aligns with the global regulatory trend of reducing unnecessary animal testing.
Since March this year, the Ministery of Food and Drug Safety has operated a review system that allows biosimilar developers to consult in advance on whether a phase 3 clinical trial is necessary. It also published the guidance Considerations When Deciding to Conduct Comparative Efficacy Clinical Trials for Biosimilars to help corporations establish development strategies.
The Ministery of Food and Drug Safety expected that the time and expense required to develop biosimilars will decrease due to this system improvement, boosting the global competitiveness of domestic corporations.
An official at the Ministery of Food and Drug Safety said, "While reflecting global regulatory trends, we rationalized data submission requirements within a range that secures safety," and added, "We will continue to improve regulations based on scientific evidence and safety to actively support the growth of Korea's biopharmaceutical industry and its overseas expansion."