Unbiased Analysis of Today's Healthcare Issues

A biologic by any other name would smell as sweet?

Written By: Jason Shafrin - Aug• 24•14

How important is a name?  In the case of biologics and biosimilars, billions of dollars depends on whether biosimilars can share the same name as branded biologics.  WonkBlog explains the biologic vs. biosimilar debate:

Biologics, which treat serious diseases like cancer and multiple sclerosis, are usually more expensive than conventional drugs, and they’re also harder to make. Unlike traditional drugs made from chemicals, biologics are made from the proteins of living organisms. So that also makes it impossible to exactly duplicate biologics, but copy cat “biosimilars” are near-replicas of these drugs and have been selling at about 20 percent to 30 percent lower than the biologic price in foreign markets.

Biosimilars are still waiting to break into the United States, though. By one estimate, the U.S. market for these drugs will grow from virtually nothing to $36 billion by the end of the decade…

The question comes down to this: Should biosimilars be allowed to share the same as the biologics they’re substituting, similar to the way generic drugs share an identification with the brand-name product. The answer to this question will likely help determine how widely biosimilars will be used when they’re approved in the United States.

…last week, 10 groups representing specialty physicians urged the FDA to require unique names for biosimilars, citing the difficulty of trying to copy the original biologics among other reasons. “Distinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly.”

The results of this ruling will have large implicaitons for patients, payers, policymakers and physicians throughout the U.S.

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