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  1. \u5907\u6ce8\uff1a\u535a\u5b89\u751f\u7269\u5730\u8212\u5355\u6297BA6101\u548cBA1102\u7684\u66fe\u7528\u4ea7\u54c1\u4ee3\u53f7\u5206\u522b\u4e3aLY06006\u548cLY01011<\/li>\n
  2. FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015<\/span><\/li>\n
  3. EMA. Guideline on similar biological medicinal products. CHMP\/437\/04 Rev 1. 2015<\/li>\n
  4. PMDA. Guideline for the quality, safety, and efficacy assurance of follow-on biologics. 2009<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

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Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015 EMA. Guideline on similar biological medicinal products. CHMP\/437\/04 Rev 1. 2015 PMDA. 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