Journal of Bioanalysis & Biomedicine

Alok Bandyopadhyay

Publications

• Review Article
  Complexities of Biosimilar Product
  Author(s): Alok BandyopadhyayAlok Bandyopadhyay
  
  Biosimilar Act, passed in 2007 under 351(k), states that a biosimilar product should be “highly similar” to prior approved reference product (RLD) and will have “no clinically meaningful differences” in their safety or efficacy. FDA also published three guidances to support this biosimilar project. However, the biosimilar processes are not so smooth. The biological molecules, manufacturing processes, and impurities profiles are complex; leaving various issues in deriving different sections of CMC work. Due to relative complexities in producing biosimilar product small differences in the design and execution of manufacturing process can have a large influence of product related-, process related-,or host related impurities protein profile of a finished product, which may trigger immunogenicity and changes the clinical profile requiring elaborate animal studies a.. Read More»
  DOI: 10.4172/1948-593X.1000091

  Abstract PDF