Under the FDA agreement, the biosimilar application fee will be waived for a small business submitting its first biosimilar biologicalproduct application.
The bottom line is that for the time being, from a regulatory perspective each biosimilar version of an approved biologicalproduct will be regarded as, in effect, a completely new and distinct drug.
Co-published by UNESCO and UNU, the volume is the product of an inter-agency partnership that also includes the Secretariat of the Convention on Biological Diversity and the UNDP GEF Small Grants Programme.