Are Biosimilars Safe?

Are biosimilars safe?

When they have been approved by the FDA or another country's regulators, then yes, of course they are.

The Washington Post published a piece yesterday that showed that there are some who are calling the safety of biosimilars into question.

Let's step back a second and remind ourselves of what biosimilars are and why this is important.

A biosimilar is sort of like a generic drug. A generic drug is a copy of an approved drug. The approved drug is kind of broken down to the chemical formula can be copied. The generic version is usually sold for less money -- the original drug is allowed to have exclusive rights to selling the drug for a period of time, which allows the company to make back the money they spent on research and marketing. After that period of time, other companies are allowed to develop their own generic versions.

Like a generic drug, a biosimilar is a copy of something that has been approved already. The difference is, a biologic is not made from a chemical formula. It is made from something living. That makes it more complicated to copy, but it can certainly be done. The FDA has approved 16 biosimilars. The European Medicines Agency has approved 40 of them.

And that approval is important. It means the FDA (or the EMA, or another regulator) has looked at the test data and made sure that the biosimilar does the same job as the original -- it is as effective and as safe.

So why would some people want to question the safety of biosimilars?

Well, like generic drugs, biosimilars can be sold for much less money. (The Washington Post article says they can 10% to 50% cheaper than the originals.) So the makers of the originals have good reason to have patients use the originals and not the copies.

The article does not mention specific people, companies, or organizations that are raising doubts.

So what does this mean for us as Follicular Lymphoma patients?

So far, there is only one biosimilar approved for FL by the FDA. It is a replacement for Rituxan. It was approved a couple of months ago, so I'm not sure how widely it has been used. (I'd be interested in hearing from anyone who has had a Rituxan biosimilar, in the U.S. or elsewhere.)

If a biosimilar is an option, and you've done some research online about it, be careful. If you come across something that questions its safety, even if it's from someone within the cancer industry. The best person to talk to is your doctor.

I assume that everyone reading knows enough at this point to question things that we read online, especially treatments that are not approved. Maybe a friend of a friend allegedly had success with a juice treatment, or someone on a message board went to Mexico and allegedly got cured. But those treatments are not proven and have not been approved. We know better than to put our faith in false promises.

So it's kind of weird that we have to question what people say about treatments that have been approved by the FDA.

But it's a good lesson, I guess. Whatever the treatment is, we should know enough about it to have an informed conversation with our oncologist. We should come out of the conversation with information about its effectiveness, and about its safety. That's what it means to be an empowered patient.