The Approved Biosimilar Count Is Up To Four, But…
As a category for medication, biosimilars are still very new. They’re an offshoot of biologic medications, drugs which use living cells as part of the production process or otherwise consist of large molecules like proteins. With smaller chemical compounds, you can reliably create a batch and feel confident that every last molecule looks exactly the same, but there’s some room for error in the biologic drug creation process. Plus with proteins, even the way the molecule folds over itself is important.
However, while biologic medications have a margin of error, they also have some wiggle room for success. You don’t need to create an exact, perfect copy of a protein to have it work correctly, and it’s thanks to this that the biosimilar category can exist. A company can create a biosimilar drug by using a different process to create a different molecule that acts identically to an existing drug, and this can act as an effective form of competition for a drug that may never get a true generic even after the patents expire because of the expensive manufacturing process.
To encourage companies to get on the biosimilar train, the FDA created a special fast-track approval system that gets biosimilar drugs to the market quickly so long as they can prove they’re functionally identical to an existing drug. In late September, 2016, the FDA approved the fourth drug to use the biosimilar track – but there is a catch. Partly because the biosimilar trend is so new, and partly because pharmaceutical companies aren’t very fond of competition, several biosimilar drugs are stuck in legal limbo over patent infringements and other intellectual property issues.
Unfortunately, if you need medication, you can’t afford to wait for the years it can take for cases to clear the courts and for generics or biosimilars to hit pharmacy shelves. That’s why it never hurts to carry a USA Rx pharmacy discount card, which can get you discounts of up to 75 percent off of prescription medications. Over 60,000 pharmacies nationwide accept our card, including all the major chains, and while our discounts don’t stack on top of insurance copays, they don’t come with any coverage limits, either.
If you’re interested in learning more about us, such as our employer partnership program, you can email us at [email protected] or call our toll-free number at 888-277-3911.