Despite 16 biosimilars in the US, over 100 molecules await entry due to high development costs favoring big pharma. Recombinant proteins and monoclonal antibodies are potential biosimilar candidates, but lower market products face barriers. Regulatory agencies have eased guidelines for some drugs, yet comparative efficacy testing remains costly. Big pharma opposes changes, and biosimilar associations oppose the Inflation Reduction Act, which removes price negotiations if biosimilars are available. The author proposes reducing development costs by 70-80% and creating a biological Drug Master File for biosimilars to streamline development.