Under the current system, patent protection is critical for developing a new therapy. The large clinical trials required for obtaining regulatory approval can cost tens of millions of dollars, and patent royalties are how this investment is recouped and rewarded. ...
Generics and Biosimilars represent two quickly growing approaches to developing drugs outside of the current patent system. Combined, there was a realized savings of $330 Billion dollars in 2020 [1, 4]. These numbers are growing quickly and novel new research ...