Approval for Rituxan Biosimilar

Last week, the FDA approved a second biosimilar for Rituxan. This one is called Ruxience (the first one, approved last November, is called Truxima).

A little bit of background and reminder:

A biosimilar is kind of like a generic drug. It follows the same formula (in a sense) as a treatment that has already been approved, and has probably been around for a long time. The difference is that a generic drug is chemical -- once you have the chemical formula for the drug, it should be pretty easy to recreate it. that's what a "generic" is. It's usually cheaper because the company making the generic didn't have to spend millions or billions of dollars developing  it.

A biosimilar works the same way -- someone else already developed it, and a new company is coming in and trying to make a copy. But a biosimilar is harder to make than a generic. A generic is made from a chemical formula. I biosimilar is made from something that is or has been alive. Rituxan is made from mouse cells. Re-creating it is trickier than it would be for a generic.

Because of this, biosimilars go through the same FDA trial process as any new treatment. The FDA wants to be sure the biosimilar is as effective as the treatment it is copying, and with the same level of side effects.

Ruxience passed the test. It has been approved as a replacement for Rituxan as a first treatment, as a combination treatment with chemo, as a maintenance treatment -- really anything that Rituxan would be used for for Follicular Lymphoma.

And because the makers of Ruxience didn't need to do all of the developmental work that the makers of Rituxan did, it should be cheaper. In theory, you now have three choices instead of one, in terms of using Rituxan.

But the reality is a little different. Old habits die hard, and some oncologists may want to keep using Rituxan instead of a biosimilar, because that's what they've been using since 1997, and they know it works, so why mess with it? It will be interesting to see how many oncologists are willing to change to one of the biosimilars.

But there's a second hurdle. The companies that made the original treatments have issued patent challenges on some biosimilars, making legal arguments that the biosimilars are too close to the originals. This has delayed some biosimilars from being available to patients. Truxima is one of them -- it was approved over 6 months ago but still hasn't been available. (The Biosimilars Council issued a report last month that said these legal challenges have cost patients over $1 Billion, since they could have been using the cheaper biosimilars.)

So this is great news -- to me, more choices is good for patients, especially when those choices have the potential to save us money on treatments. But there are some potential problems to overcome before that happens.