At almost $900 a pop, it’s probably no surprise that we get lots of questions about generic Prolia. If you are a postmenopausal woman at risk for osteoporosis, Prolia is one of the most commonly-prescribed treatments to prevent osteoporosis, but unfortunately, it’s also one of the most pricey, so we get questions all the time about What’s going on with generic Prolia? When is generic Prolia going to be available? And is generic Prolia ever going to come out?
And unfortunately, if you’re looking for a cheaper, more affordable substitute for Prolia like a generic, there’s not a whole lot of good news. Prolia is a “biologic” which isn’t subject to the same laws and rules as traditional prescription drugs for generics. Because of the way that biologics like Prolia are made, it’s really unlikely that there will be a generic version of Prolia anytime in the near future, if ever. For years, the most profitable drugs—mostly pills made of chemicals—have been fairly easy for generics companies to copy, requiring a straightforward chemical synthesis. But the next wave includes more-complicated inhaled drugs like Advair and others made of complex biological ingredients like Prolia. Replicating them will require skills that many generics makers don’t yet have.
Even if technology improves and the laws regarding biologics change, prolia is protected by a fistful of patents, so the chances of a generic version of Neulasta in the near future are pretty dim. Last year, Amgen which makes Prolia was able to get the patent for another of its biologic drugs, Enbrel, extended for another 16 years. Yes, that means that it is going to be at least another 16 years before it’s even possible for Enbrel to become available in the U.S. And we wouldn’t be surprised if Amgen tries to fight to keep the Prolia patents as long as possible too, which would keep generic Prolia off the market indefinitely.
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