Before the end of the year, the FDA plans to release a set of guidelines to approve generic versions of biological drugs, a class of pharmaceuticals including enzymes, antibodies and other molecules derived from living cells, but approving generics of biological drugs might not be as simple as approving generics of traditional drugs, according to a report in the Scientific American.
In 1984, the Hatch-Waxman Act approved a similar set of guidelines for approving traditional generic drugs, which now make up more than 60 percent of U.S. prescription drug sales. The act is estimated to have saved the healthcare system $734 billion between 1999 and 2008.
The author argues that generic biological drugs are too complex to ride on previous approvals of brand-name drugs. For example, aspirin weighs 180 daltons, the unit of measure for anatomic mass. The biological drug interferon beta weighs 19,000 daltons. The components in aspirin are created in a laboratory, but the components of interferon beta are harvest from living cells, which make the final product more prone to variation.
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In 1984, the Hatch-Waxman Act approved a similar set of guidelines for approving traditional generic drugs, which now make up more than 60 percent of U.S. prescription drug sales. The act is estimated to have saved the healthcare system $734 billion between 1999 and 2008.
The author argues that generic biological drugs are too complex to ride on previous approvals of brand-name drugs. For example, aspirin weighs 180 daltons, the unit of measure for anatomic mass. The biological drug interferon beta weighs 19,000 daltons. The components in aspirin are created in a laboratory, but the components of interferon beta are harvest from living cells, which make the final product more prone to variation.
Related Articles on Pharmaceuticals:
Bristol and Pfizer Anticlotting Drug Gets FDA Priority Review
FDA Approves Expansion of BioMarin Pharma Plant
Commentary: Pharmaceutical Companies More Careful About Off-Label Promotion