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Why are some states standing in the way of cheaper versions of biologic drugs that the FDA deems safe? An editorial appeared in the Los Angeles Times on Sunday which discusses how biosimilars can help reduce some of the costs of an expensive healthcare system.

The Los Angeles Times reports:

The debate over biosimilars is grounded in doubts about their safety; none have yet been approved for use in the United States. Proponents of a bill by California Sen. Jerry Hill (D-San Mateo) to regulate the dispensing of biosimilars include critically ill patients who fear that the new medicines won’t match the biologics they rely on, as well as doctors who prescribe and study biologics. Supporters also include the biotechnology companies whose expensive biologics account for about a quarter of U.S. pharmaceutical revenue — a share that’s expected to reach $100 billion in 2015.

On the other side stand the generic drug companies that want to make biosimilars. They see measures like Hill’s as a thinly veiled attempt by leading biologic manufacturers Amgen and Genentech to hold off competition. They’ve won support from U.S. Food and Drug Administration Commissioner Margaret Hamburg, who warned against reducing the public’s confidence in biosimilars. She recently predicted that competition from biosimilars would “spur innovation, improve consumer choice and drive down medical costs,” just as the generic versions of brand-name pills have done.

Clearly, patient safety has to be policymakers’ top priority. But state lawmakers shouldn’t substitute their own judgment for the FDA’s scientific analysis. And they need to balance the very real needs of the patients taking biologics against the public’s interest in affordable healthcare. That’s why they should be wary of impeding the arrival of biosimilars that the FDA deems interchangeable with their biologic counterparts.

Read more: Battle over ‘biosimilars’

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Comment Preferences

  •  Birth Control. (0+ / 0-)

    Personally I would not take the pill or suggest it.

    Premarin is the question here. Replicating that study is problematic.

  •  This is not a really clear cut issue (6+ / 0-)

    Obviously there are huge corporate interests on both sides. And I work for one.

    Chemical drugs are identical however they are manufactured -aspirin is aspirin, Vitamin C is Vitamin C, valium is chemically identical to its generic equivalents. It's very easy to prove they are exactly the same compound and hence no difference in effectiveness or safety or stability.

    Biologically manufactured drugs are "made" not by chemists but by living cells. They are highly complex (where I work, one new drug takes 18 months to manufacture a batch!) collections of conjoined biological molecules. They don't have a chemical formula and it would be really difficult, maybe impossible, to prove that Brand X is identical to what is manufactured by Amgen or Genentech.

    I don't claim to have a magical solution, just want to point out it's not as simple as Brand Name Overpriced Corporate Greed Bad, Generic Inexpensive Bood.

  •  As someone that had a very bad reaction (0+ / 0-)

    To synthetic hormones, I have a concern that these biosimilar products may defeat the purpose for having the biological medications.

    As with the synthetics, what looks like a small change could lead to very bad reactions. Cheaper does not always equal better, or even adequate.

    Women create the entire labor force. ---------------------------------------------------------------------------------------- Sympathy is the strongest instinct in human nature. - Charles Darwin

    by splashy on Thu Mar 21, 2013 at 07:32:30 PM PDT

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