Archive for March, 2009

Make Way for Biogenerics

March 8, 2009
The Boston Globe

FOR DECADES, patients have benefited from the lower prices of generic drugs after name-brand patents have expired. Now, government officials want to do the same for a new type of drugs called biologics, which are based on living cells.

But the biotech companies that devise and produce these complex new drugs are at odds with the generic manufacturers that want to get into the market. The dispute is so deep that biotech officials refuse to call the copycats “generics” or “biogenerics,” since those terms carry a suggestion of duplication. Biotech prefers to call them “follow-on” drugs or “biosimilars.” The two sides are so deeply divided that Congress has not been able to legislate ground rules for approval of the knockoffs by the Food and Drug Administration.
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