Prior to March 23 2010, there was no regulatory pathway for biosimilar development in the US.
It was then that the President signed the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) into law, which amended the Public Health Service Act (PHS Act) and created an abbreviated review pathway for US biosimilars.
Although the pathway is abbreviated, similarities to the Reference Product must be proven with rigorous data and the guidelines are stringent. Biosimilar sponsors must demonstrate that the proposed compound is highly similar (biosimilar) to or interchangeable with the Reference Product.
Not surprisingly, the first biosimilar was not approved in the US until 2015. This brief description of biosimilars illustrates a variety of the challenges to consider as you contemplate your next development project.