Rituxan Biosimilar Approved in Europe

Earlier this month, the European Commission gave its approval for Ruxience, a biosimilar for Rituxan (Rituximab, MabThera -- all the same treatment). Ruxience was approved for use the United States last year.

As you might remember, a biosimilar is sort of like a generic drug -- a copy of a treatment that is as effective and safe as the original treatment, but maybe cheaper to use.

Biosimilars are a little different from generic drugs, because they are made from somethng that is or was alive ("bio" means "life."). That makes things trickier than a generic drug, which is made from chemicals. Making a generic drug is like following the recipe for a cake. Making a biosimilar is like trying to figure out how to copy the eggs.  

But, like generic drugs, biosimilars should be cheaper than the original. When someone develops a treatment (like Rituxan), they generally have exclusive rights to that "recipe" for a certain number of years. This lets them make back all of the money they spent on developing the treatment, testing it, and marketing it. After that time period, other companies are allowed to try to copy it. They must then test the copy in clinical trials to make sure it really is a copy -- as safe and effective as the original. But because they didn't spend all of that money developing it, they can sell the biosimilar to patients for less money (at least in theory).

Rituxan has been a very successful treatment, not just for Lymphoma, but also for Multiple Sclerosis and Rheumatoid Arthritis.

Ruxience is the second biosimilar for Rituxan/MabThera approved by the FDA (the first is called Truxima).  Both have been approved for use in Europe now, too.

Interestingly, the the application for two other Rituxan/MabThera biosimilars were withdrawn recently. Not sure about the first one, but the second one wasn't able to provide the data necessary to show it would be as safe and effective as the original.

The good news, though, is that many people have access to treatments that may be as effective and safe as Rituxan/MabThera, which we know has been a huge hep for those of us with Follicular Lymphoma.