Recent changes in the healthcare system have put a greater focus on the development and availability of generic drugs. The pharmaceutical industry has responded by exploring alternative delivery methods, creating new test designs and, most notably, developing the first American biosimilar. These advances have been met with acclaim, but they do bring new challenges. Regulatory ambiguity in testing procedures delay generic developers, and legal action from originator drug companies restricts those focusing on biosimilars. This summit will further explore the scientific necessity of this subject, while guiding experts through their collective difficulties.