LG Life Sciences, Ltd. - Comment

A. Biosimilarity -Although there is minor difference between the proposed biosimilar product and the reference drug in the the extent of characterization possible undertaken using state-of the-art analytical methods, the applicant should have chance to check and prove that the difference is not clinically relevant. -Although there is difference in excipient, i.e.,human serum albumin, it should be regarded as biosimilar based on the comparability in physico-chemical analysis data, pre-clinical and clinical data. B. Interchangeability - For immunogenicity aspect, extensive safety monitoring should be performed after switching to the proposed interchangeable biological product from the reference product. C. Patient Safety and Pharmacovigilance -Any specific safety monitoring imposed on the RBP or product class should be incorporated. -Potential additional risks identified during the review of the data obtained with the SBP should be subject to further safety monitoring (e.g. increased immunogenicity that might result from a difference in the glycosylation profile). D. The Use of Supportive Data and Information Animal or clinical data comparing a proposed biosimilar product with a non-U.S-licensed comparator product should be used to support a demonstration of biosimilar to a U.S.-licensed reference product, based on that the physico-chemical and biological comparability between U.S.licensed reference product and non-U.S-licensed reference product. To scientifically justify the relevance of the comparative data, physico-chemical comparability study should be accepted. E. Definition of a Biological Product It should be limited to recombinant protein product at first and extended to other categories later. Continued...