All About Biosimilars

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Bradley Martin, NextGen Alumnus
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Being someone with type 1 diabetes, I can relate to insulin prices being absurdly high. My name is Bradley Martin, a 2021 NextGen Fellow for CDN. Pursuing a bachelors in Digital Media Studies at the University of Rochester, I find it difficult to afford both tuition and medical bills. I am fortunate enough to be able to afford my insulin, but there are many in this world who cannot. They are forced to ration their insulin or develop other unhealthy habits that result in many unfortunate hospitalizations and even deaths. Something has to be done about the high insulin costs at once!

Luckily, there is a new drug approved by the FDA that can help this problem. I had the chance to interview Jill Olexa, Director, Medical Portfolio Lead for Biosimilars for Viatris to talk about their new product, Semglee, which is one of the biosimilar insulins approved today with the potential to lower costs for those who need long-acting insulin. Jill helped me understand what a biosimilar is. After having this conversation, I feel hopeful biosimilar products can help reduce the paywall for many who are struggling to afford their insulin costs.    

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"I feel hopeful biosimilar products can help reduce the paywall for many who are struggling to afford their insulin costs."

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Q:What is a biosimilar insulin? How is it different from the insulin I use now?

Insulin is a biologic product, which are medicines created from living cells that treat some of the most challenging diseases such as cancer, autoimmune diseases, diabetes, etc. These biologic products are very useful but can be very costly. Biosimilars are a biologic alternative that, when compared to a reference brand product, have no clinically meaningful differences in safety and efficacy. Not only do biosimilar medications offer more treatment options but are often priced lower than their reference products. This can potentially reduce cost for patients, which is a great step towards giving everyone access to insulin. Some people may still be wary to use biosimilar medication due to its novelty and lack of awareness of its effectiveness, but Jill assured me that all FDA-approved biosimilars are put through a rigorous evaluation that ensures their safety, effectiveness, and quality.

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"Not only do biosimilar medications offer more treatment options but are often priced lower than their reference products."

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Q: Are biosimilars a new type of drug?

Biosimilars have been around for many years. Jill explained that Europe pioneered the introduction of biosimilars about 20 years ago. Today, they are generating more than 2 billion patient days of clinical experience. From what I learned, this is a well-defined type of medication that has been helping patients get more options with their treatment for many years now. Despite biosimilars being around for decades, there are still many medications that have not received a biosimilar counterpart. Medical advancements happen every day. I think the development of this new biosimilar drug is a strong step towards making sure everyone, regardless of disease, chronic condition, etc. has multiple options when it comes to their health treatment.

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"Interchangeability is when a medication is so similar to another that it doesn’t make a difference which one you use—the same results should occur."

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Q:  What is the difference between non-medical switching and interchangeability?

According to Jill, non-medical switching is a term that refers to a change in medication for a non-medical reason such as insurance plan formulary driven changes between medications that are thought to be therapeutically equivalent but are different in structure as a way to save on drug costs. Interchangeability means that it can be completely substituted for another product. So a biosimilar with an interchangeability designation meets additional requirements by the FDA to conclude it may be substituted with its reference product at the pharmacy. From my understanding of what Jill said, non-medical switching is when someone in the medication chain (doctor, insurance company, pharmacy, etc.) decides they want the patient to get a different medication primarily for reasons unrelated the safety, adherence or how well the medication works.

Because of this, they give them a medication that is not identical but has the same clinical results after use. Interchangeability is when a medication is so similar to another that it doesn’t make a difference which one you use—the same results should occur (makes sense given the name).

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Q: Are there approved biosimilars in the US? What about not in the diabetes space?

The first biosimilar treatment was approved by the U.S. FDA back in 2015, Jill mentioned. Since then there have been 31 biosimilars approved by the FDA from 9 reference products. There are 2 biosimilars for the insulin Lantus available today. Although I think the number of biosimilars available is on the smaller side, I’m confident companies undergoing research and development can produce new ones offering more options to the consumers.
 

Q: Are biosimilars used in other countries for diabetes treatment?

Jill responded to this by talking about the increase in prevalence of diabetes globally. This has resulted in the use of biosimilars for diabetes to gain momentum. Outside of the US, there are currently a large number of biosimilar insulins available, and this number continues to grow. The hope is an increasing number of patients and healthcare systems will benefit from biosimilar use in the near term. In my opinion, this is a good thing to hear from Jill. From my understanding, biosimilars are much more relevant outside the US and have been for quite some time. We are seeing a push for more biosimilars around the world, which can help everyone get the medication they need at an affordable price. So perhaps we will see an even greater increase of biosimilars in the US as the momentum for the treatment keeps growing.

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"So perhaps we will see an even greater increase of biosimilars in the US as the momentum for the treatment keeps growing."

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Q: How will biosimilars impact diabetes treatment in the coming years?

Biosimilars and the increase of interchangeability will help create more competition in the healthcare marketplace which may translate into a reduction of cost for patients in healthcare systems. Jill continued by mentioning a recent report that a more robust biosimilars market could save the US as much as 54 billion dollars over the next decade, however, we must collectively work together as an industry to address the barriers to access that exist in the system today to realize the full potential of savings.      

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I think Biosimilars have a chance to significantly relieve the burden of high medical bill costs to the consumer, which could result in many lives being saved… but it will take the entire industry to work together to get to that point. The ever-increasing amount of biosimilars on the market is a good sign things are heading in the right direction.

I would like to thank Jill for meeting with me and Viatris for allowing us the chance to interview. This opportunity has been very enlightening for me as a person with type 1 diabetes, and everything Jill said in the interview was insightful and informative. I would also like to thank CDN for giving me the chance to conduct this interview. As a NextGen Fellow, I appreciate everything CDN does to support us and to offer new experiences that help develop our professional careers. Overall, it's clear that we have a lot of work to be done to help everyone who cannot afford their insulin. But as more biosimilars such as Semglee are developed, I’m confident this type of product can reduce the burden of medical costs and save lives around the world.


Editor's note: Viatris is a CDN Corporate Member, and sponsor of Off to College.

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Bradley Martin
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Bradley has had type one diabetes since 2013 and joined CDN in his first year at the University of Rochester studying digital media studies and computer science. Working as business manager, Bradley balanced funds for his Chapter while also planning events to educate others about life with type one. He was the BGM Marketing/Customer Relationship Management Intern at Ascensia Diabetes Care for a year before joining CDN as a NextGen Fellow. In his free time, Bradley enjoys working on computers and playing video games. Expressing his love for tech and passion for type one diabetes, he hopes to work in the diabetes technology field.