Saturday, February 25, 2017

Rituxan Biosimilar Approval

A biosimilar for Rituxan has been approved for use in Europe. It is called Truxima, and will be available in the UK, Germany, Italy, Netherlands, Belgium, Republic of Ireland and Luxembourg.

Some background: Cancer treatments cost money to develop. When they fail, the company that develops them loses money. So be it -- it's the risk those companies take. But when they are successful, they can make billions of dollars for the business. Rituxan (also known as Mabthera is other parts of the world) is one of those successes.

The company that creates a successful treatment gets exclusive rights to that treatment for a set number of years. In a sense, this a reward for their taking the risk to do the research and testing that goes into a successful treatment.

But that reward doesn't last forever. After that set period, other companies are allowed to create "biosimilars" -- copies of the treatments that work in the same way (and, after some testing, with the same results).

A biosimilar isn't the exact same thing as the original. That's right in the name -- it is "similar" to it. The company that makes the biosimilar also has to invest in production. They have to figure out what the original treatment was, and test whether or not it will work. But they don 't have to spend money on marketing the treatment, the way the original maker had to. The biosimilar is coming into a situation where people already know that it works.

And so for that reason, biosimilars are (or should be) less expensive than the original. A lot of the cost of the treatment has already been paid. The hope is that Truxima will save patients and healthcare systems lots of money because it will be sold cheaper than Rituxan/Mabthera.

There is a chance that doctors will not prescribe the biosimilar, and will stick to the original, for whatever reason. And there is a chance that, for some patients, the biosimilar will be just different enough from the original that it  won't work as well. (My wife takes a medication that just won't work in the non-original form.)

But overall, I think biosimilars are a good thing. The biosimilar version of Rituxan will likely be in the news sometime this year. I'll keep an eye out.


Anonymous said...

Hi Bob, very interesting, thank you. In my work, I manage my company's Employee Health Plan, and this happens to be for a Pharmaceutical Company, so I am privileged to see both sides of the coin. All these biological drugs are very expensive and are driving insurance premiums up, but many of them are changing lives . It was easy for a Generic company to copy a regular drug ( in pill, capsule, liquid form)once the patent was up. They followed a recipe and the production instructions and voila, the same drug for a fraction of the price. My understanding is that these biologicals are quite the challenge, and they cannot be called Generics because it is impossible to clone a living drug unless 100% of the circumstances/environment is exactly equal- and only the original producer can do that.
This is how it was explained to me in layman's terms: If you own a vineyard in California and want to grow a specific type of wine that comes from France, you can acquire a plant from that exact wine from that very vineyard in France and plant it in similar type of soil in a similar climate and follow the instruction's to grow and harvest the grapes and make the wine in the exact same fashion, but you will never get the exact same wine.
That being said, it's possible that the Retuxin biosimilar will work just as well, or who knows, maybe better and for a fraction of the price!
Thanks again for all the info you provide. I am 3.5 years post RCHOP and going strong. Glad you are too!

Lymphomaniac said...

Thanks, Lilly -- that's a great explanation. And it makes sense that it's different from a chemical generic, which can kind of follow a recipe. (I like to think of it as like making Scotch; the barley is going to grow differently, the yeast might behave differently, the water isn't consistent, and you can't control the wood in the barrels. Hard to make it all come out the same.)
Now I need a glass of wine and/or Scotch.
Congratulations on the 3.5 years post-RCHOP. Stay healthy!