Biosimilars

Biosimilars or biogenerics, are generic non-patented chemical and therapeutic equivalents of brand name biopharmaceutical drugs. 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. However, biogenerics are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics.

Industry participants are struggling with what to call these hybrid forms of biologics that will be created by the generic companies.

The worldwide prescription generic drug market has stood the test of time and has endured numerous growing pains. However, it has evolved into a formidable and important participant in the complex world of health care. Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market.

Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process may facilitate bringing products to market. While there are many issues to address, the outlook for the promotion of biosimilars is favorable in the next five years.