Biologics, or biopharmaceuticals, are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biogenerics are not generic biologics, because there can technically be no generic form of biologics. That is, the complex process of creating biologics, means that traditional definitions of bioequivalence used in the generic drug industry do not (or may not) apply. Industry participants are struggling with what to call these hybrid forms of biologics that will inevitably be created by the generic companies.
This report describes the complex regulatory and technical issues involved in the emerging biogeneric industry and forecasts the potential size and growth of the market for currently off-patent and soon-to-be off-patent biopharmaceuticals by analyzing likely candidates, their current market value, and any generic development underway.