Physicians Write Letter To FDA Regarding Biosimilar Naming Concerns

On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the implementation of the Biologics Price Competition and Innovation Act (BPCIA).

Unlike traditional small-molecule prescription drugs, most biologics are complex and are typically made from human or animal materials.  The BPCIA provides an abbreviated licensure pathway for biologics that are demonstrated to be "biosimilar" to or "interchangeable" with an FDA-licensed biologic.  A biologic may be demonstrated to be "biosimilar" if data show that, among other things, the product is "highly similar" to an already-approved biologic.  Unlike "generic" versions of small-molecule prescription drugs, biosimilars are not bioequivalent to their reference biologics.  To date, the FDA has not approved any biosimilar products.