Author Archives: Sean Philpott

Review, Approval, and Marketing of Biosimilars in the United States

    Development, testing, review, approval, and marketing of biosimilar drugs in the United States presents unique safety and regulatory challenges (1). By contrast with traditional small-molecule drugs, biologics derive from sources such as genetically engineered cell lines, plasma, and tissue specimens (2,3). Patents on first-generation biologics approved and marketed in the United States have begun to expire, thereby opening the market to less-expensive “generic” versions. The complexity of biologic drugs and the specificity of their source materials, however, make…

Review, Approval, and Marketing of Biosimilars in the United States

    During the past 30 years, advances in medicine and pharmaceutical research generated a new class of drugs called biologics. These drugs are complex proteins, carbohydrates, or other large molecules derived from biological sources (1). By contrast with more traditional pharmaceuticals (small-molecule drugs), biologics are not synthesized chemically from less complex components, but rather are derived from or manufactured using living organisms or extracted tissue (2) Biologics make up a small but significant percentage of the overall pharmaceutical market.…