RE:RE:RE:Egrifta Quote:"...
Biologics, such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a
Biologic License Application (BLA), rather than an NDA. The manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, requiring a somewhat different approval process.
Generic drugs that have already been approved via an NDA submitted by another maker are approved via an
Abbreviated New Drug Application (ANDA), which does not require all of the clinical trials normally required for a new drug in an NDA.
[14] Most biological drugs, including a majority of recombinant proteins are considered ineligible for an ANDA under current US law..."
Does it mean there would be no biosimilar (generic) to compete with Egrifta ?