INFO - Why are biologics so expensive?

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Arthritis Foundation

Arthritis Today

Drug Guide: Biologics

Excerpt:

Why are biologics so expensive?

The materials required to create these agents are more expensive, and

the manufacturing processes using live organisms are more complex than

are required for traditional chemical pharmaceuticals. Other factors

include the high cost of research and development.

All of the current biologics are still under patent protection. After

a traditional drug patent expires (20 years from the date the company

applies for it), other companies can produce generic versions that

cost less.

It’s not clear yet how generic biologics – frequently called

“follow-on biologics” – will be handled. The unique process of

producing copies of biologic agents presents issues of consistency, as

well as proof of safety and effectiveness. The U.S. Food and Drug

Administration (FDA) currently has no authority to approve a follow-on

biologic for the marketplace, but there are bills in Congress to

change this.

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http://www.arthritistoday.org/treatments/drug-guide/types-of-drugs/drug-guide-bi\

ologics.php

Not an MD

[Guest guest]

Thank you for all the great info!

As always!

Michigan