Two more blogs weigh in on the FDA guidelines published for the Biosimilar approval route last Thursday. The Patent Doc blog seems a bit underwhelmed by the lack of specificity of the guidelines but acknowledges the FDA had a relatively short time line to issue their guidance. It does acknowledge the guidelines will likely evolve in practice and the FDA gave itself maximum flexibility in interpreting them. The FDA will use a "totality of evidence" standard similar to that adopted in Europe.
The BioProcess Blog for its part seems a little more upbeat that the FDA put guidelines out there to get the process rolling. In general, it was positive about the fact the FDA will allow the possibility of formula changes and different delivery devices from biosimilar to the reference product without either being an automatic block to taking a biosimilar path. The blog authors were also happy that the FDA will accept data from non-US licensed products in considering the "totality of evidence" in support of a biosimilar application.
To date the FDA has received 31 requests for meetings to discuss company plans for their biosimilars, and 21 of those had been held by the end of December 2011. There have also been 9 INDs for biosimilars filed to date and the agency is expecting a full 351(k) application soon. The process is well underway and there is still 60 days for interested parties to comment and suggest changes to the Draft guidelines just issued.
Posted by Bruce Lehr Feb 15th 2012.