RESUMEN
OBJECTIVE: To discuss the critical questions on the development and evaluation of biosimilars. METHODS: Topics such as the option of developing approach and evaluation method, the original concept and understanding of biosimilars, the challenge and risk of developing biosimilars, the chapter and items related to application of biosimilars in regulation for drug registration, etc., were addressed in combination with the drafting of guidance on biosimilars. RESULTS AND CONCLUSION: It was recommended that comparative studies applicable for candidate drugs be designed and appropriate developing approach be selected refering to the guidance on biosimilars. The manufacturing process, scale, and batches used for the comparative studies should be evaluated in terms of representativeness and rationality. The technical requirements as well as the challenge and complexity for the judgement of similarity should also be well understood. The decision on developing biosimilars should be made based on risk analysis and comprehensive understanding of the internal characteristics including critical quality attributes of the reference products and candidate drug.