FDA: Generic biotech drugs require paradigm shift

 
(Ref: CNBC)
  • According to an article published in the NEJM, US regulators suggested that the approval of biosimilar drugs "will require a new paradigm of sponsor-FDA interactions," involving analysis of much more data than traditional generics, as reported Wednesday on CNBC.
  • "Given the complex nature of biologics, it's unlikely that a 'one size fits all' systematic assessment of biosimilarity can be developed," FDA officials, including the head of its drugs centre, Janet Woodcock, said in the article.
  • Thus, approval guidelines are likely to be product-specific and all-encompassing, examining the "totality of evidence" available about a particular class of biotech drugs.
  • Although new technologies can more accurately describe the unique "fingerprint" of a biotech medicine, while this technology is in its early stages, extra animal and clinical trials will still be required "for the foreseeable future," the officials wrote.
  • The FDA indicated that it may have to review everything from the specific populations targeted by drugs and the process by which they are made, after which the regulator would suggest what clinical trials are necessary to verify any remaining doubts.
  • "The FDA is currently considering how such interactions [with companies] might be structured and how they will affect the user-fee programme that Congress has mandated for biosimilars," the FDA noted.