Rituxan Substitute?

More Rituxan in the news. (What is the deal with Rituxan these days? Two posts about Rituxan in a row? It's been around forever, but still manages to make news. It's becoming the Joan Rivers of cancer treatments, for crying out loud.)

Anyway, Rituxan is in the news because its patent expires in 2018, meaning other companies can make generic versions -- and sell them cheaper. (A big chunk of the cost of a drug comes from recovering all of the research and development that went into finding, creating, and testing the drug, which can take years. Generics don't have to do all of that work, so they don't have those costs to recover. So, we get cheaper drugs.)

The big issues with generics is that they need "biosimilarity." This is where things get complicated. Many generic drugs are made by recreating a chemical. (It's more complicated than that -- not many of us can make our own home version of ibuprofin or something like that -- but it's fairly straightforward.) Biosimilarity involves drugs or medical products that are produced by living organisms. This includes Rituxan, which is made from mice.

So creating a biosimilar of Rituxan is a lot harder. It's more than just mixing chemicals in a lab; it's trying to duplicate the entire process of creating something that is itself created from a living organism. And when you're dealing with stuff that is or used to be alive, you've got a whole bunch more factors to control that are potentially hard to control.

Of course, the original manufacturer of Rituxan isn't going to make this easy by offering any help.

An article in this month's Leukemia and Lymphoma describes a European attempt (successful) to create a biosimilar version of Rituxan. It's for a medical journal, so it's fairly thick reading, but I think a version aimed at a more popular audience would make for fascinating reading. There are deadlines to be met, with scientists frantically trying to copy things. There are "freshly purified human natural killer cells." And there are two monkeys. They don't have names, but when I write my screenplay based on this article, the monkeys will be called Johnny and Gonzalez. And nobody but my father will get that joke.

Anyway, it's pretty interesting reading, and maybe makes us appreciate how difficult it is to develop the original version of a treatment, let alone a generic version.

It will be interesting to see how the patent expiration plays out, and what we get as a result. Cheaper monoclonal antibodies? Maybe something just a tiny bit better? or a tiny bit worse?

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A quick note about the next couple of weeks:
I'm off on a vacation with the family, and unlike the vacations I usually take, this one will leave me with limited internet access. I plan to post to Lympho Bob every few days, because it's important to me to keep up with it. But the posts will definitely be shorter, and maybe have some longer stretches in between. My plan is to get back to my usual blogging habits when I get back near the end of the month.