FDA Issues Proposal on Generic Biotech Medications

First App Launched to Identify Drug Shortages
First App Launched to Identify Drug Shortages
All biotech drugs to carry a four-letter code to distinguish brand name, generic versions.

HealthDay News — A proposal for identifying lower-cost generic biotech drugs has been released by the U.S. Food and Drug Administration.

Many newer biotech drugs cost more than $10,000 a year and this class of drugs accounts for nearly 30% of all drug spending in the country, according to the Associated Press. Earlier this year, the agency approved the first biosimilar drug, the term for generic biotech drugs.

Under the FDA proposal, all biotech drugs would carry a four-letter code to help clinicians and pharmacists distinguish brand name and generic versions, the AP reported. 

Public comments on the proposal will be accepted for 60 days before the FDA moves to finalize the rule.

Generic biotech drugs have been available in Europe since 2006 and about 20 have been approved there, the AP reported.

Learn more about the proposal.