A reminder about biosimilars and why they matter for Follicular Lymphoma patients:
Think of biosimilars as like "generic drugs." A drug that could be used for, say, treating a cold, has exclusive rights for a set number of years. The company that developed the drug gets the chance to get back some of the money they spent on that development by being the only company that can make the drug. After that time expires, other companies can develop their own generic versions. They are usually cheaper because they didn't need to spend money on developing the drug.
But generic drugs are fairly easy to make. The drug has a chemical formula that can be copied.
Biosimilars are sort of like generic drugs, in that another company has developed a treatment and then has the right to be the only company to sell it for a set number of years. However, biosimilars aren't drugs that can be copied by figuring out the chemical formula. As the name implied, they are made from living things, and that makes it a whole lot harder to copy them. But like generic drugs, when they can be shown to be as safe and effective as the original, they should be cheaper.
But dealing with living things is a lot harder than copying a formula.
So that's where we are with this proposed biosimilar. The FDA issued a Complete Response Letter saying it will not approve the application (at least not yet).
[To be clear, a "Complete Response Letter" doesn't have anything to do with the term "Complete Response" that describes a patient who has gone into remission from a treatment. A Complete Response Letter means the FDA has completed its review of an application for approval of a treatment, and is sending bad news. Same words, but different meanings. Unnecessarily confusing, if you ask me.]
I haven't seen the Complete Response Letter anywhere (I don't know if they are made public), so I don't know what exactly the FDA was concerned about.
The bad news is, this means a possibly cheaper Rituxan biosimilar won't be available as soon as many would have liked. Cheaper treatments (assuming they are still safe and effective) are good for patients.
The good news is, the company has not given up on getting the biosimilar approved. In their press release, they say that they are "committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible." So their plan is to address the FDA's concerns and try again.
This biosimilar has already been approved for use in Europe, so there must be some good to it.
In the meantime, we as patients can hope that new treatments, and cheaper versions of old ones, continue to be developed and made available to us.
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