chapter  Chapter 7
32 Pages

U.S. commercialization

WithSarfaraz K. Niazi

Biosimilars have increasingly become an important and somewhat controversial topic in the healthcare space. While the United States is moving toward a more definitive pathway to biosimilar approval and usage, biosimilars are not known to most of the world. Amgen and Pfizer both have multiple biosimilar products in the development stage and are aiming to capture market share of some of the largest selling biologic products, such as Humira. Competition in the US biosimilars market will be unlike competitions in any other pharmaceuticals segment for multiple reasons. Group Purchasing Organizations play an important role in the value chain for a pharmaceutical. Specialty distributors are specifically equipped to handle expensive and often high touch specialty drugs. In the academic world, drugs tend to be classified as specialty if they require a difficult or unusual delivery process, and the drug requires patient management.