Cancer treatment has come a long way over the years. At the forefront of these medical advances are therapies known as “biologics.” Today I am speaking with Andrew Spiegel from the Global Colon Cancer Association to talk about biosimilars in cancer treatment and how he has used his voice in patient-centered policy and other discussions to ensure safe biologic medicines are available and accessible to patients.
About Andrew
Spiegel has a long and personal history with colorectal cancer. In 1998, Spiegel’s mother was diagnosed with metastatic colon cancer. She exhibited numerous symptoms, which were ignored by her physicians, and died nine months later. It was then, that Spiegel and a group of others founded the Colon Cancer Alliance, the leading United States-based national patient advocacy organization dedicated to colon cancer.
Mr. Spiegel, an attorney, besides being a co-founder of the organization and longtime board member of the Alliance became CEO in January of 1999 and he ran the CCA for nearly 5 years, before undertaking his next venture, the Global Colon Cancer Association.
Spiegel is a member of the National Colorectal Cancer Roundtable and is on the Stand Up to Cancer Advocate Advisory Council. He serves on the steering committee of the Alliance for Safe Biologic Medicines, on the Board and Membership Committee of the Digestive Disease National Coalition (DDNC), is a member of the Coalition for Imaging and Bioengineering Research and is a member of the Computerized Tomography Coalition as well as an active member of many other health care coalitions and organizations. Spiegel is currently co-chair of the DDNC. In 2012, Spiegel received the David Jagelman Award for Patient Advocacy from the American Society of Colon and Rectal Surgeons.
Spiegel is a 1986 graduate of Temple University in Philadelphia where he earned a Bachelor’s degree in Political Science with minors in English and Philosophy. He is a 1989 graduate of the Widener University School of Law where he was an editor of the Delaware Law Forum, an invited member of the Phi Delta Phi legal honors society and a member of the Moot Court Honor Society. After working for a Philadelphia litigation firm, Spiegel opened his own law firm in 1995 and was a participating member of numerous legal organizations in the region. Mr. Spiegel resides with his wife and three children in the suburbs of Philadelphia, Pennsylvania.
Transcript
Adam (00:00):
Cancer treatment has come a long way. Over the years at the forefront of these medical advances or therapies known as biologics, biologics are powerful and complex drugs made from biological products like antibodies or proteins, and can come from all sorts of living sources, animals, plants, and even bacteria. In the last few years, biosimilars agents that are highly similar to biologics for breast cancer treatment have been developed and introduced into the clinic. Today. I’m speaking with Andrew Spiegel from the global colon cancer association to talk about biosimilars in cancer treatment and how he has used his voice in patient centered policy and other discussions to ensure a safe biologic medicines are available and accessible to patients. Andrew, welcome to the show.
Andrew (00:48):
Thank you, Adam. Thanks for having me.
Adam (00:50):
Thanks for joining me. This is a, is a complex gushing. I hope you’re going to make it easy for us, but let’s start off. Tell us just about yourself and what you’re working on.
Andrew (00:59):
Again, I’m Andrew Spiegel. I am the executive director of the global colon cancer association. We are an organization that is made up of the 50 groups around the world that deal with colon cancer from the patient advocacy side. I’ve been in the colon cancer advocacy arena since co-founding the US-based colon cancer Alliance way back in 1998, 1999. So I’ve been in this space for over two decades and have really seen some really significant changes in, in medicines and in healthcare over that time that I’m happy to talk about.
Adam (01:31):
Wow, I can, I can only imagine what you’ve seen. I mean, Madison seems to be advancing so fast year over year in the last 20 years, it’s just really come a long way. So what’s a biosimilar. Walk me through it.
Andrew (01:41):
So the best way for me to describe in a non-medical way, what is a biosimilar is to start with first, what is a biologic? And a biologic is a form of a drug, a form of a therapy that people get. Now there’s over 1 billion people around the world now who have benefited from biologic therapies. So these are the state-of-the-art types of therapies, and it’s not just in cancer. This is across diseases and skin diseases and rheumatology and oncology. And really across the board, the biologics have made a really significant impact in the lives of patients, both making their lives better and extending lives. Of course for those who have serious diseases like cancer biologics, as you mentioned, they’re made from living cells, living proteins, they’re they’re alive. And what’s different about that is that we’re used to typical drugs being administered here by pills.
Andrew (02:37):
We go to the pharmacy, we pick up our pills, those are called chemical drugs. So what we have to do is compare chemical drugs to biological drugs, to really know the difference. And the real difference is that a chemical drug is made from what you would expect to be chemicals. I give you the recipe, Adam, to make aspirin. It’s a really small, it’s really easy to make, and I could give you the recipe to make aspirin and you could go and make aspirin with the ingredients just as well as bear aspirin can make aspirin because that’s a chemical recipe. You we’ll have the recipe to make that chemical drug. You can make it just as well as everybody else, as long as you follow that recipe. And as long as you use the same chemicals, right, it’s expected that those chemical drugs will stay the same, no matter who’s making those because it’s just simply following a recipe and no matter who makes the recipe, it should basically be the same.
Andrew (03:33):
And that’s why for chemical drugs that everybody’s used to, the pills that we get at the pharmacy or from the doctor, that’s why we’re used to generics being around, okay. Generics have proved over the years that they’re simply safe and they’re simply just as effective because you simply follow that same recipe to make the same chem chemical drug. When we’re talking about, about biological drugs, it’s a different type of conversation. And that’s because these biological drugs are made from living organisms. So I could give you Adam the same recipe and you could try to follow the same recipe, the problem for you in making what would be called a generic to our biologic drug is that you don’t have access to the same ingredients. Unlike that making of aspirin, I could tell you exactly what aspirin is made of. You can make it, I could tell you what a biologic is made of, but because it’s made from an individual cell line, I have access to that individual line of cells.
Andrew (04:34):
And so the best that you can make is what we call a biosimilar. Okay. Not an original biologic. Okay. It’s a biosimilar. It’s similar to the originator biologic drug. And that’s the main differences between the chemical drugs that we’re used to at a biological drug. The main difference being that you can’t duplicate educated identically, like you can with a, with a generic drug. One of the other differences between a biological drug and a chemical drug is the sheer size of it. Okay. If you, if you looked at the molecular makeup of aspirin, you could simply draw a quick schematic and it would be a very, very simple molecule to make. If you’re looking at a biologic, like a monoclonal antibody uses for cancer and in a biologic, it would be comparing the makings of a bicycle to a jet fighter. That would be the difference. It would be comparing to a one bedroom apartment to a hundred story, apartment building, right size. It’s the sheer size of it. And the complexity of the model fuel that separates them from simple drugs, known as chemical drugs to these very complex, large biological drugs. So those are the main differences between biologics and chemical trucks that actually helps
Adam (05:58):
A lot and helps me to kind of wrap my mind around sort of how to think about this. So understand the difference between biosimilars and biologics. And we understand that how they’re different from generic drugs. I guess what assurances do people have to know that biosimilars are safe and are going to be effective?
Andrew (06:15):
So let’s say a doctor prescribes a patient at biologic biological drug for their condition, right? It may well be that now there are biosimilars out for that drug patients should feel very comfortable that if a biosimilar has been approved by the FDA or by EMA, or by the who a really high level regulatory body, they should feel very comfortable that that drug is both safe and effective for them to take with a biological drug and the FDA and other regulatory bodies have set for the standard for approval. And you have to prove that these, these biosimilars are highly similar to the originator biologic, and that there are no clinically meaningful differences in terms of efficacy or safety. Okay. So that’s the kind of data that’s required. You don’t have to do patient studies. You don’t have to run a clinical trial on your biosimilar because the idea behind the entire idea behind biosimilars is, is the same as it was for generics.
Andrew (07:23):
You’re trying to lower the cost of medicines, right, by lowering the cost of medicines that makes them more accessible, ideally to patients and to providers. And so if you can produce a biosimilar at a cheaper cost than an originator biologic, because you don’t have to run the same kind of clinical studies you did that makes them less costly to produce, makes them less costly for the patient at the pharmacy or at the hospital to get that biosimilar. So again, again, if the, if the regulator has approved it, you could feel pretty comfortable that your bias similar is just as safe and just as effective as the originator product.
That’s fantastic. So you mentioned availability. I’m curious about that. How available are biosimilars to healthcare providers and then subsequently to patients?
Andrew (08:12):
So the United States started developing a pathway for biological products and about 2010, about 11 years ago Europe had started much before that, a number of years before that. And so Europe has had quite a headstart and having biosimilars on the market and they really have proved to be very safe and very effective in Europe, but in America, they’ve they’ve only been out for a couple of years, but in those couple of years to date, there are 29 approved biosimilars in the United States approved by the FDA and of those 29 approvals. I believe there’s about 19 that are being marketed currently. And I think there’s at least five for breast cancer while five biosimilars for breast cancer that are being marketed. So biosimilars have really penetrated the United States market recently and really around the world because regulators around the world are realizing that these are safe and that these are effective and they are saving money. They’re saving significant money in Europe where these prices are coming in, you know, 15, 30% in some places, 60, 70, 80% lower than the originator biologics. And that’s not the norm, but definitely cost savings that are happening. And billions here in the United States will be saved by the use of biosimilars and they are available. They’re they’re available and there’s many more coming.
Adam (09:36):
Wow, that’s amazing. So I know this is, this is your area of expertise. So I’m happy to ask you this. So I’d love to talk a little bit about how biosimilars have benefited colon cancer patients, to help us understand how they may also benefit breast cancer patients.
Andrew (09:53):
What we have seen around the world and in the colon cancer community specifically, is that there actually is data that shows when biosimilars are introduced into a healthcare system, that the costs, the overall payout of the healthcare system is lower. And that the increased availability of the drug to more patients is greater. So that more patients get access to drugs. They wouldn’t otherwise get access to you’ll see, in some countries around the world that some regulators, some payers, some, some healthcare payers will only cover biosimilars because they’re cheaper. And so in a CA if you’re in a country where you cannot get access to the originator biologic, but you can get access to the lower cost by the similar there’s proof positive that these biosimilars increased the number of patients, they can access to these important drugs. And we have seen that in the colon cancer space and in other disease areas around the world.
Andrew (10:46):
And I fully expect to see that happen in the United States where everybody’s paying less and they’re having more treatment options. So the one promise of getting lower cost biosimilars is accomplished. Plus there’s increased treatment options. Then maybe there’s times when a healthcare provider wants to prescribe a biosimilar to a patient after having a discussion with that provider and with that patient. And then there’s times that a healthcare provider may not want a patient to be on a biosimilar. And where we usually see that is where you have a patient who has multiple co-morbidities or multiple healthcare issues. Sometimes it took that patient like an auto-immune patient. It took that patient 10, 20 years to find the right cocktail of biologics for them to live a normal life. And most are in agreement that you don’t want to mess with that person’s cocktail, that’s working for them, right.
Andrew (11:38):
I can see in the breast cancer community, as these biosimilars become more available, these conversations happening and patients have to have these conversations with their doctors about which drug is right for them, and then be prepared if they’re their healthcare provider decides that there’s a difference between what they want the patient get and what the insurer wants the patient to get, be prepared for that battle to happen. But I think the big takeaway from, from this whole conversation on biosimilars and biologics is that patients should not be scared to take a biosimilar. They should not be nervous about it. They’ve been proven, especially if it’s coming from a reputable company that’s been around and doing biologics and biosimilars for a long time and an, an a a top notch regulatory body, like an FDA or EMA or health Canada, or one of those have approved this drug. I think the patient should feel very safe that that that drug could be effective.
Adam (12:33):
Yeah, no, that man that is, that is great. Andrew you’ve taken an incredibly complex topic and you’ve made it understandable and digestible. And I think most importantly, you’ve helped us to see that with the introduction of biosimilars, there are going to be more options available, more, more choice, and hopefully ideally lower costs in the future. So thank you so much for your time today for joining us on the show.
Andrew (12:57):
It’s my pleasure, Adam. Thank you for having me and thank you for covering the topic.
Sponsors
This episode is sponsored by Amgen Oncology.
At Amgen, we are committed to the relentless pursuit of breakthroughs for cancer patients and their families. We have a deep and diverse pipeline of cutting-edge therapeutic approaches that aim to improve outcomes.
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