Biosimilar Act, passed in 2007 under 351(k), states that a biosimilar product should be ââ?¬Å?highly similarââ?¬Â to prior\r\napproved reference product (RLD) and will have ââ?¬Å?no clinically meaningful differencesââ?¬Â in their safety or efficacy.\r\nFDA also published three guidances to support this biosimilar project. However, the biosimilar processes are not so\r\nsmooth. The biological molecules, manufacturing processes, and impurities profiles are complex; leaving various\r\nissues in deriving different sections of CMC work. Due to relative complexities in producing biosimilar product small\r\ndifferences in the design and execution of manufacturing process can have a large influence of product related-,\r\nprocess related-,or host related impurities protein profile of a finished product, which may trigger immunogenicity and\r\nchanges the clinical profile requiring elaborate animal studies and human clinical studies. FDAââ?¬â?¢s guidance is not very\r\nclear to drive the product into regulatory pathway for approval. Complexities still exist in clinical studies as clinicians\r\nlike to review the details of data from three phase 3 trials and payors wish to see more stringent data regarding\r\nsafety and efficacy. However, EMA developed a centralized path for the approval of Biosimilar product and so far\r\nEMA approved 16 products.\r\nOne of the remedies is that if the biosimilar product is purified to homogeneity or near homogeneity, and if it is\r\nstabilized and restores the functional activities, the impurities protein content will be negligible or minimum, which may\r\nnot trigger the immunogenicityor other clinical issues. With more advancement of science, research and development\r\nmay solve these issues and open the easier regulatory pathway for biosimilar approval. Interchangeability and price\r\nreduction issues may be solved at that time.
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