Fun with blogging

This from BiG has just become the crux of a piece that someone will pay me for:

r, US pricing of insulin is a classic example of regulatory unintended consequences. It’s regarded as a drug in the US, but because of the nature of the product it is impossible to produce a “generic” insulin. In Europe it is regulated as a biological product (which it is), opening the way to demonstrate that “generics” (biosimilars, technically) are as good as without demonstrating they are identical at the molecular level. In the US that route is not open to “generic” competitors to the 3 big insulin manufacturers.

The FDA will catch up with the rest of the world next year and you will see sensible insulin prices in the US from around 2021/2022 onwards.

I guess beer is owed…..

4 thoughts on “Fun with blogging”

  1. Bloke in Germany in London

    Also shows 3 producers is not sufficient to generate much price competition. You see that same effect with niche generic drugs, eplerenone off the top of my head, where the originator is (I think) no longer marketed and 3 generic manufacturers sell it at around 200 euro a pack, which is more typical of a patent med than a generic.

  2. Pcar
    It baffles me. WTF invests in the FAANGS?
    Facebook: buy any old shit that might pose competition
    Amazon, so bereft of ideas they are opening high street supermarkets
    Apple /MS buy for the yeild, mature businesses
    Google, the Standard Oil of clicks
    and so on.
    As for airBnB, Uber,Wedrinklager etc, they are just BORING.
    I wonder if the NASDAQ itself is some giant Ponzi scheme.

  3. Certainly under the 2010 Biologics Price Competition and Innovation Act (and you know with a name like that it isn’t helping price, competition or innovation) insulin will be regulated as a biologic beginning in 2020. That will have some impact as stock turns into flow because the FDA’s policy is that any insulin application that’s still pending on March 20, 2020, will be rejected. Any applicant would then have to start over and reapply under a new biosimilar pathway. Given the long timeline for drug development and the slow and uncertain FDA approval process, the 2020 deadline has discouraged other drug makers to submit a potential generic insulin application for several years. Even companies who have insulin products in development and are ready to file their applications with the FDA are now waiting to apply until after 2020, given they want to avoid going through the time and money of applying in 2019 and having to potentially re-apply afterwards. The FDA (or Congress) could almost certainly change this hard-line approach, but haven’t.

    However, there are other factors which will still impact price in the context of the US Healthcare system.

    Sanofi, Eli Lilly, and Novo Nordisk manufacture insulin. These companies set artificially high prices for their drugs in order to gain preferred status within the insurance companies’ lists of covered drugs by ‘discounting’ them, and the various bits of the supply chain have different negotiating power. As list prices increase, the profits of the intermediaries in the insulin supply increase since each may receive a rebate, discount, or fee calculated as a percentage of the list price.
    Each of the three also has hundreds of unexpired patents related to their products, the delivery devices, and manufacturing processes and they vigorously defend their formulations against cheaper biosimilar versions. Sanofi recently brought lawsuits against both Merck and Mylan to avoid production of biosimilar versions of its biggest selling insulin product. http://apps.who.int/medicinedocs/documents/s22481en/s22481en.pdf
    Finally, many doctors are reluctant to prescribe older insulin products — the ones that are eligible for generic competition https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/premium/csaph/insulin-affordability.pdf

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