Thursday, February 16, 2012

FDA Releases Draft Guidance on Biosimilars

A week ago, the FDA released three documents to comply with the Biologics Price Competition and Innovation Act (BPCI Act) to create competition within the biologics space.

  1. Q&A for BPCI Act
  2. Scientific Considerations of Biosimilarity
  3. Quality Considerations of Biosimilarity
Why is the bankrupt U.S. government passing more laws to empower the FDA on this matter? Basically because the markets created biologics faster than the FDA was able to respond and this is essentially catch-up.

You see, unlike small biological molecules, large biological molecules (called "biologics") cannot be feasibly or economically synthesized with chemical reactions. Biotech companies differ from pharma companies because they genetically engineer microbes to secrete the complex biological molecules and then produce a lot of it with fermentation or cell culture.

The FDA has long held:

Quality cannot be tested into the product

I was at this IBC Conference once where a professor got up and said, "No one knows this to be more true than academia... each year we test our students more and more, and each year they don't get any smarter."

It has long been insufficient for drug companies to produce a drug that meets product quality specifications when substitute raw materials were used or procedures not followed during the manufacture of the drug.

Applying this rule to biologics, it would hold that anyone who doesn't have the original cell line used to manufacture the name-brand biologic would violate this FDA dogma and thus be forbidden from selling their biologic in the US markets.

In essence, there's no way for the FDA to allow biosimilars into the US markets without throwing everything they've been doing out the window. This lack of a regulatory pathway forbids biologics made by companies other than the original manufacturer to be sold in the U.S, thereby handing US biotechs monopolistic power.

This is why there's a BPCI Act in the first place. It is to force the FDA to create a pathway for generic biologics to enter the US markets and induce competition.

Watching the FDA on biosimilars has become a spectator sport for the wonkish Regulator Affairs folk. The folks over at Bioprocess Blog cover this much more thoroughly.

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