At some point in your experience with Ulcerative Colitis (UC), you might have heard of a biologic called Humira. Humira, also known as Adalimumab, is one of several biologics that can be used to treat UC. Recently, Humira biosimilars have been a frequent discussion topic on the news.12 This blog post will tackle what biologics and biosimilars are and discuss how biosimilars may leave behind a bit more cash in your pocket.
What are biologics and biosimilars?
Humira is a biologic often used when other medications aren’t effective or for severe UC.14 Biologics are made from living cells and target the body’s immune system to control disease and symptoms7. In UC, biologics help reduce inflammation and symptoms. Humira is a tumour necrosis factor (TNF) blocker and reduces inflammation by blocking TNF.1
Biosimilars are very similar versions of biologics that are created after the original biologic’s patent has expired.6 The biosimilars are typically approved by the FDA once they are tested to be just as effective and safe as the original biologic. Biosimilars usually are sold at a lower cost compared to the original biologics because less money is required for research and development.
Which biologics are used for ulcerative colitis?
Biologics are often used for moderate to severe UC or when other treatment options aren’t effective.
You would typically see these biologics for UC14:
- Adalimumab (Humira)
- Infliximab (Remicade)
- Golimumab (Simponi)
- Vedolizumab (Entyvio)
- Ustekinumab (Stelara)
What is Humira again?
Humira is often given as an injection under the skin, into the fatty tissue.1 Depending on the individual, the medication may be given every few weeks at home or the doctor’s office.
Humira can be used for a number of conditions and is approved for the following conditions1:
|Approved for adult use only||Approved for use in adults and children|
|Rheumatoid arthritis||Polyarticular Juvenile Idiopathic Arthritis (Ages 2 and older)|
|Psoriatic arthritis||Crohn’s disease (ages 13 and older, weighing 40 kg or greater)|
|Ankylosing Spondylitis||Hidradenitis Suppurativa (ages 12 or older, weighing 30 kg or greater)|
|Plaque Psoriasis||Uveitis (ages 2 or older)|
|Ulcerative Colitis (ages 5 or older)|
Common side effects that you may see include1:
- pain, redness, or swelling at the injection site
- upper respiratory infections
More severe side effects include serious infections, allergic reactions and changes to blood tests.1 Your doctor will typically go over a few things before giving you a biologic. This includes:
- vaccination history
- infection history
- other lab work
Several biosimilars for Humira have already been created. The biosimilars currently approved by the FDA include5:
So several biosimilars have already been available for many years and your doctor may decide to prescribe them over Humira. Why is the topic of Humira biosimilars hitting the news right now? The reason why the Humira biosimilars are a hot topic right now is that Abbvie extended their patent in 2016 for 6 years, which meant that Abbvie had legal protection to sell Humira exclusively until now.13
Why are patents important?
Patents and exclusivity allow companies to research and develop medication without the fear of being unable to recoup their costs.8 This usually means the original biologic is sold at a high price compared to the biosimilars that are made. However, patents don’t last forever, which promotes companies to develop new drugs and patients to benefit from lower costs after the patent expires.
Are biosimilars just as effective and safe?
Before the FDA can approve a medication as a biosimilar, clinical studies need to be conducted to show that the biosimilar is just as safe and effective when compared to the original biologic.6 To make the biosimilar, companies study the original biologic and figure out how it works in the body. They usually study how it works, what the body does with the medication and its side effects experienced with the medication.
Clinical studies with a large of number patients are completed to directly compare the biosimilar with the original biologic to ensure that they work the same.
For example, Amjevita was tested and compared to Humira in people with severe rheumatoid arthritis and severe plaque psoriasis.3,4 As you may know, Humira and Amjevita are approved to be used for many different conditions including UC. However, the FDA doesn’t require a company to directly test their biosimilar for all conditions Humira is approved for so long as the biosimilar is effective, safe and works the same as the original drug.6 However, it is important to note that currently only Humira is approved to treat hidradenitis suppurativa or uveitis.1
Other notable facts
Another notable difference between Humira and Amjevita is that Amjevita and other biosimilars will be made citrate-free.11 It has been studied that the ingredient citrate can make injections more painful. With the biosimilars being citrate-free, there may be less pain with each injection.
It is important to note that not all biosimilars will be interchangeable, which means your pharmacy may require permission from your healthcare team to change back and forth between the original biologic and biosimilar. More studies are typically needed to decide that a biosimilar is interchangeable with its original biologic.
Price difference between Humira and Amgevita
Currently, the price of Humira in the United States is around $7,299 for a supply of 2 kits and each kit contains 40 mg/0.4 mL.2,10 The pricing model of Amgevita intends to be 55% cheaper than Humira at wholesale acquisition cost or 5% cheaper than the Humira list price.
Market price changes
In the past, each addition of biosimilars increases the competition for biologics and reduces the market price.9 You would typically see a decrease in the original biologic’s prices and its related biologics because of the shift in supply and demand. With more and more biosimilars for Humira being introduced throughout the year, we should hope to see the price for this medication decrease and become more accessible.
- Biosimilars are introduced into the market to increase competition, provide more options for patients and decrease prices
- Biosimilars are designed to be identical to the original biologic
- Humira biosimilars have not been studied to treat hidradenitis suppurativa or uveitis
- Just like the newer version of Humira, some of the biosimilars will be citrate-free, making injections less painful
- Abbvie. Product monograph including Patient Medication Information – AbbVie. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/HUMIRA_PM_EN.pdf. Published September 16, 2022. Accessed February 22, 2023.
- Amgen. AMJEVITA™ (Adalimumab-Atto), first biosimilar to Humira®, now available in the United States. Amgen. https://www.amgen.com/newsroom/press-releases/2023/01/amjevita-adalimumabatto-first-biosimilar-to-humira-now-available-in-the-united-states. Published January 31, 2023. Accessed February 22, 2023.
- Amgen. Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis. CTG Labs – NCBI. https://beta.clinicaltrials.gov/study/NCT01970475?tab=results. Published October 20, 2016. Accessed February 22, 2023.
- Amgen. Study to compare efficacy and safety of ABP 501 and Adalimumab (humira®) in adults with moderate to severe plaque psoriasis – full text view. Full Text View – ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT01970488?term=abp%2B501%2Bor%2Bamjevita&draw=1&rank=3. Published December 13, 2016. Accessed February 22, 2023.
- Biosimilar Drug Information. U.S. Food and Drug Administration. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Published December 19, 2022. Accessed February 22, 2023.
- Biosimilar Product Regulatory Review and approval – food and drug … Review and Approval. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf. Published December 13, 2022. Accessed February 22, 2023.
- Center for Biologics Evaluation and Research. What are “biologics” Questions and answers. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers. Published June 2, 2018. Accessed February 22, 2023.
- Center for Drug Evaluation and Research. Frequently asked questions on patents and exclusivity. U.S. Food and Drug Administration. https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a. Accessed February 22, 2023.
- Frank RG, Shahzad M, Kesselheim AS, Feldman W. Biosimilar Competition: Early learning. Health Economics. 2022;31(4):647-663. doi:10.1002/hec.4471
- Humira prices, coupons, Copay & Patient Assistance. Drugs.com. https://www.drugs.com/price-guide/humira. Accessed February 22, 2023.
- Junker S, Ebert O, Bartsch R. A systematic literature review of injection site pain perception in adult patients treated with citrate-free and citrate-containing biologic agents. Current Rheumatology Reviews. 2022;18. doi:10.2174/1573397118666220829123713
- Khemlani A. America’s top-selling drug Humira loses monopoly status. Yahoo! News. https://ca.news.yahoo.com/america-top-selling-drug-loses-173623041.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAANvXzOgLCAJnzdNXzU8zBg0BElXHnIpJmtCBqajesqXu3ENQBzltHqp811pETZsqik5P7EQqGSlOi-QqXaDyToH6z10njTzrEwS5CkRo5yXESvGVaQzIFkRmhvLBNpjxCzmbU10Ylug8Trf1b2eJsJyEwgyilEGfJ5WtLrDyR3GQ. Published February 1, 2023. Accessed February 22, 2023.
- Loftus P. AbbVie, Amgen Reach settlement in Humira Patent Dispute. The Wall Street Journal. https://www.wsj.com/articles/abbvie-amgen-reach-settlement-in-humira-patent-dispute-1506635070. Published September 28, 2017. Accessed February 22, 2023.