Saturday, July 8, 2017

Rituxan Biosimilars for Follicular Lymphoma

There has been a bunch of news about biosimilars for Rituxan in the last month or so. Again, this is kind of old news, but it's worth mentioning because it affects so many people -- there is biosimilar news for Europe and the U.S.

First, some background.

When treatments like Rituxan are approved, they come with a time limit. No one else is allowed to sell something similar for a set period of time. This is fair -- the company that developed the treatment spend many years and a lot of money working on the treatment in the laboratory, then through clinical trials, and then regulatory processes. That period of time gives the company exclusive rights to the treatment, letting them make up those costs and earn a profit.

After that period of time, other companies are allowed to develop copies that are probably cheaper. (They are cheaper because the company that developed them also has to market them and get people to want them. Companies that make the copies don't need to pay for marketing and advertising.)

Those copies can take different forms. Most of us are familiar with generics. You get a headache, you can buy Tylenol or another brand-name painkiller. Or, for a little less, you can buy acetaminophen, a generic version. Generics are fairly easy to create. They follow a chemical formula. Mix up the elements the same way (a little carbon, some hydrogen, whatever), and you'll get the same thing every time.

[In school, I did really well in biology, and really NOT well in chemistry. You probably suspected that.]

Biosimilars are different than generics. Generics are about chemistry, with atoms that will always behave the same way, and give a predictable result. Biosimilars are about biology -- living things -- and they don't always behave the way we would like them to. So creating a biosimilar is harder. It needs to behave the same way, go after the same protein on the surface of the cancer cell (CD20), stay in the body for the same length of time, spread around the body in the same way, be as safe, and be as effective for a long time. That's a lot for a copy to do.

And yet, some companies have managed to create biosimilars for Rituxan, and they seem to be working.

About a week ago, the FDA (in the U.S.) accepted an application for CT-P10, a biosimilar for Rituxan. The decision for this will probably come in early 2018. (It's trade name will be Truxima, and the FDA request is based on some really good trial results presented at the International Conference on Malignant Lymphoma in Switzerland last month.)

About 3 weeks ago, the European Commission approved a biosimilar for Rituxan (known as MabThera in Europe). The biosimilar is called Rixathon.

Acellbia, another Rituxan biosimilar, will probably be approved next month in India. It is already approved in Bolivia and Honduras under the name USMAL.

Patients and doctors will have the option to go with Rituxan (and I'm sure many will), or with the biosimilar. Insurance companies and healthcare systems that pay for the treatment might be more enthusiastic about the less expensive alternative.

The important thing, to me as a patient, is that we have options. If, for example, an insurer is able to lifetime cost cap, then a cheaper treatment with similar safety and results is obviously a very good thing, especially for a disease like Follicular Lymphoma that might require many different treatments over time.

And this is probably a good time to say Thank You to Rituxan. you've given me seven and half good years without treatment, and probably extended the survival of thousands of Follicular Lymphoma patients. We certainly owe you that much.


AgPepper said...

like you said, more options - but I would have a hard time not going with Rituximab (Rituxan) if I ever needed it.

Lymphomaniac said...

Yes, I think it will be kind of a leap of faith for people to take the biosimilar, though I'm sure some people won't have much of a choice.....