USP monograph supports biogenerics development

The Generic Pharmaceutical Association (GPhA) said the US Pharmacopeia’s (USP) monograph validates the science underlying generic biopharmaceuticals and shows that biopharmaceuticals can be characterized.

“Although the brand industry has argued that biopharmaceuticals cannot be adequately characterized, this monograph clearly shows that the technology and the science exist to characterize some of these medicines. USP’s action further supports the establishment of an abbreviated approval process for generic biopharmaceuticals,” said GPhA president and CEO Kathleen Jaeger.

At a scientific public forum held in February 2005, scientists from the FDA and MIT acknowledged that the science exists to create and characterize glycan products and other generic biopharmaceuticals. Examples include insulin, human growth hormone, antibiotics, and monoclonal antibodies. The release of USP’s monograph, which addresses product standards for somatropin, further bolsters support for the science.

GPhA is continuing to urge the FDA to immediately release its white paper and agency guidances on biologics, which would provide timely advice to the industry. Four years ago, the FDA announced that it would be working on the agency guidelines for insulin and human growth hormone, but has yet to release them.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry.

Generics represent 53% of the total prescriptions dispensed in the US, but less than 12% of all dollars spent on prescription drugs.