Rituxan Biosimilar Approved

The FDA has approved a Rituxan biosimilar, called CT-P10 or Truxima. The approval is for some B Cell Lymphomas, including Follicular Lymphoma.

It's a potentially big deal.

A biosimilar is kind of like a generic drug. Generics are a little easier to make. A drug is a chemical compound, so once you figure of the chemistry, you have a recipe to follow. A biosimilar is harder, because it's not a chemical compound, but a biological agent -- something that comes from a living thing. Copying it is a lot harder.

Think of it this way -- making a generic drug is like following the recipe to make a cake. Making a biosimilar is like trying to figure out how to get the eggs when you don't have any chickens -- just an egg that you need to make a copy of.

Finding a Rituxan biosimilar has been a goal for a while, because Rituxan has been such an important part of most B Cell Lymphoma treatments for the last 20 years or so. When a treatment is approved, the company that developed it is given a period of time when they have exclusive rights to that treatment. But after a period of time, others are allowed to try to make copies (biosimilars, in Rituxan's case) and try to get the, approved.

The FDA was satisfied that Truxima will do the same job, with the same side effects, as Rituxan.

The reason this is a big deal for patients is that, like generic drugs, a biosimilar should lower the cost of treatment. When Rituxan was first created, it cost a lot of money to do the research and then to market the treatment. That exclusive period of time gave the company time to make up all those costs.

A biosimilar (or a generic) doesn't need to make up those research costs (it's already been developed), or the marketing costs (everyone knows how great Rituxan is). So they should be able to sell the treatment at a lower cost.

It will be interesting to see how popular it becomes. Insurance companies may like it, since it should lower costs. But will oncologists trust it? Old habits die hard, and they may just keep going with what they are used to.

Interestingly, just a few weeks ago, another company that is developing a Rituxan biosimilar decided not to go any further with it in the U.S. The FDA had asked for additional data in the spring before giving their approval, and the company decided that another biosimilar (probably Truxima) would be approved before they could get the FDA what it wanted.

I'll be watching closely for any reports of Truxima's use. If anyone out there is offered it during treatment, I'd love to hear how it goes.