Are Biosimilar CLL Drugs Safe?

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Topics include: Treatments

Can biosimilar chronic lymphocytic leukemia (CLL) drugs help lower the cost of treatment? Are they as safe and effective for patients? At a recent Town Meeting in Portland, expert Dr. Jeff Sharman discussed the development of biosimilar drugs, how they work and when they are expected to be released in the market. Watch now to find out more about these drugs for CLL targeted therapy. 

This town meeting is sponsored by Pharmacyclics LLC and Janssen Biotech, Inc. It is produced by Patient Power in partnership with The CLL Global Research Foundation, The US Oncology Network, Compass Oncology, Willamette Valley Cancer Institute and Research Center, and The Leukemia & Lymphoma Society (LLS).

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Transcript

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:          

So, Jeff Sharman, some people will start reading in the paper about biosimilars. There is a biosimilar, Zytux, for rituximab (Rituxan). By the way, the map there is if you’re outside the US, Rituxan or rituximab may be called MabThera where you are. But biosimilar, made by a different company, but effectively the same if somebody that has a doctor that says, “Well, we’re gonna recommend Zytux in the combination. Should they be concerned?  

Dr. Sharman:              

So, this is kind of a remarkable development. So, in the United States, when you take a single dollar in healthcare, $0.22 goes to drugs. So, the cost of drugs is about a quarter of all healthcare. Now, there’s hospital, insurance, physicians—there are all these things. So, it is the single largest expense in healthcare.  

The patent for rituximab ended in 2018. But here’s the trick. So, when Lipitor becomes done with its patent, the general size of the pills that we take is anywhere between, say, 250 to 1,000 what we call daltons. That’s a molecular size. The molecular size of a monoclonal antibody is about 150,000 daltons. So, it’s anywhere from, say, 150 to, say, 500 times bigger at the molecular size than the Lipitor. 

So, the complexity of synthesizing this molecule is extraordinary. Think about a matchbox car versus a genuine aircraft carrier. The order of magnitude is high. So, we didn’t even have regulatory was with the FDA to say, “Can I make a ‘generic’ rituximab?” because they’re so complex. How do you make anything like that? 

So, we settled upon this term called biosimilar. Amazingly—and actually, I worked in a lab with the guy who created rituximab and seven or eight years ago, I had a conversation with him and he said, “They will never make a generic rituximab. It’s impossible.” 

Well, here we are. So, the way these drugs get approved is very different. We had to have laws passed that determine if you could actually call something a biosimilar. I think for patients who are out there, the mechanisms that are in place to say that this is adequately sufficient to be compared to—biosimilar, not biosame, not anything like that, but biosimilar is there. 

So, the first one was approved in December 2018. It has not been released into the US market, although that’s coming imminently. A second one will be approved very soon. I was involved with that one. So, ideally, this is going to help chip away at some of the cost of healthcare because a dose of rituximab costs many thousands of dollars and we’re hoping to bring those prices down. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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Page last updated on August 20, 2019