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Saturday, February 11, 2012

FDA on biosimilars

Great WSJ article today summarizing the FDA's new rules for biosimilars.

Included in the rules discussion is this list of the top 10 biologics:

While I knew they were big sellers, I hadn't realized that the big 3 RA biologics accounted for $19.5B in annual sales. That's roughly equal to the GDP of the country of Bolivia. Total sales of biologics are greater than the annual economy of New Zealand. Keep in mind, this entire class of drugs did not exist until 1989. (I'm guessing that the first FDA approved recombinant biologic was Amgen's Epo, in 1989.)

As for the newly announced FDA regulations on biosimilars, they strike me as very fair - the regs acknowledge that the biosimilars have a lower regulatory burden than a "novel" (i.e. not biosimilar) drug, yet are not considered a typical generic. As opposed to chemical generics, biosimilars will need significant data to receive FDA approval, and will not be able to be marketed as exact copies. 

1 comment:

  1. Your blog post so helpful for my EPO Biosimilars Research and Development.

    ReplyDelete