Hyrimoz vs. Humira: What’s the Difference?
Humira (adalimumab) is a powerful medication called a TNF-blocker monoclonal antibody. It’s used to treat a wide range of autoimmune conditions, from rheumatoid arthritis and juvenile idiopathic arthritis to psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. Humira is a blockbuster drug, with sales exceeding $20.7 billion in 2021.
Hyrimoz is an adalimumab biosimilar to Humira. Biosimilars are designed to have the same effects as the original drug but may come with different side effects. But what does “biosimilar” even mean?
A biosimilar is a medication that is very similar to another already-approved biological medication. Biosimilars are approved in the same way that generic drugs are approved. The primary reason for biosimilars is to reduce healthcare costs by providing more affordable treatment options.
So how do Hyrimoz and Humira stack up? This article compares the efficacy, safety, administration, and patient considerations for Humira and Hyrimoz. We’ll provide a comprehensive overview to help patients and their healthcare team make informed decisions about treatment.
What are Humira and Hyrimoz? A Detailed Overview
Humira and Hyrimoz are medications prescribed for a range of autoimmune conditions. Here’s a closer look at what they are and how they work.
Humira: The Originator Biologic
Humira is a biologic medication, meaning it’s made from living cells. It’s classified as a TNF-alpha inhibitor. TNF-alpha is a protein in your body that promotes inflammation. Humira works by blocking TNF-alpha, which reduces inflammation and eases the symptoms of autoimmune diseases.
Humira comes in several formulations, including different dosages like 40mg and 80mg, and different delivery methods, such as pre-filled syringes and auto-injectors. The 80mg dose is particularly important for people with conditions like inflammatory bowel disease (IBD) who may need a higher dose to manage their symptoms.
Recently, Humira’s been reformulated to improve tolerability. These newer versions have reduced injection volumes and different inactive ingredients (excipients) to make the injection process more comfortable.
Hyrimoz: The Biosimilar
Hyrimoz is a biosimilar to Humira. It’s important to know that a biosimilar isn’t the same as a generic drug. Biosimilars have to meet strict regulatory requirements to prove they’re highly similar to the original biologic medication. This means Hyrimoz has been shown to have similar efficacy, safety, and how the body responds to it (immunogenicity) compared to Humira.
While Hyrimoz is very similar to Humira, there can be slight differences in the inactive ingredients, preservatives, or the type of device used for injection. These differences don’t typically affect how the medication works, but they can be factors some patients consider.
Hyrimoz is available in several regions, including Europe, and is now available in the United States. In Europe, there are actually eight different adalimumab biosimilars available, offering patients and doctors more choices.
Comparing Efficacy and Safety: Clinical Trial Data
To figure out whether Hyrimoz is truly a good substitute for Humira, it’s important to look at the data from clinical trials comparing the two. These studies give us a good idea of how well each drug works and what side effects people might experience.
Efficacy Studies
Several randomized, double-blind, phase III studies have compared Hyrimoz to Humira in conditions like rheumatoid arthritis (RA) and psoriasis. The good news is that many of these studies (you can see a summary in Table 2) show that adalimumab biosimilars, including Hyrimoz, are clinically equivalent to Humira in treating RA and psoriasis. That means they seem to work just as well.
For example, studies by Cohen et al. in 2017, Fleischmann et al. in 2018, and others (Weinblatt et al. 2018, Genovese et al. 2019, Kay et al. 2021, Papp et al. 2017, Blauvelt et al. 2018, Hercogová et al. 2020, Feldman et al. 2021) have all contributed to this understanding. However, it’s worth keeping in mind that each study might have slightly different designs or include different types of patients, which can affect how we interpret the results. For example, some studies might focus on people who haven’t been treated with adalimumab before, while others include people who have already been on Humira.
Safety Profiles
When it comes to safety, both Hyrimoz and Humira have similar side effects, based on what we’ve seen in clinical trials and from monitoring the drugs after they’re on the market. That said, there are some subtle differences. For instance, some people taking Humira reported a stuffy nose or sinus pain, while some taking Hyrimoz experienced infections, rash, nausea, or high blood pressure. It’s important to remember that everyone reacts differently to medications.
One common concern with injectable drugs like these is injection-site reactions, like pain or swelling at the injection site. This can be a problem for some patients and can even make them less likely to stick with their treatment. There are strategies to manage these reactions, like using proper injection techniques and rotating injection sites.
Another thing to consider is the potential for immunogenicity, which means the body might develop antibodies against the drug. This can sometimes make the drug less effective over time. Researchers keep an eye on this in clinical trials to see if there are any significant differences between Hyrimoz and Humira in terms of immunogenicity.
Administration and Dosage: Key Considerations
If your rheumatologist has prescribed Humira (adalimumab) or Hyrimoz, it’s important to understand a few key factors about how the medication is given and the dosage you’ll need.
How it’s given
Both Humira and Hyrimoz are given as a subcutaneous injection, meaning that the medication is injected under the skin. Be sure you understand the correct technique for giving yourself an injection, because this can help to minimize pain and potential complications at the injection site.
Dosage regimens
The dosage and how often you’ll need an injection is something your doctor will determine, based on the condition you have and other personal factors. Both Humira and Hyrimoz are available in different dosage strengths, such as 40mg and 80mg.
It’s critical to follow your doctor’s instructions carefully and take the medication exactly as prescribed.
Device differences and patient training
Humira and Hyrimoz come in different forms. They may be pre-filled syringes or auto-injectors. To make sure you’re giving yourself the correct dose, you’ll need to be trained on how to use your specific device.
Never give yourself an injection until you’ve been properly trained by a healthcare professional. Your doctor’s office or the pharmacy can give you individualized instructions and support for using the device and formulation you’ve been prescribed.
Switching from Humira to Hyrimoz: Practical Guidance
If your doctor has suggested switching from Humira to Hyrimoz, you probably have some questions. Here’s what to keep in mind during the switch.
Clinical Considerations for Switching
It’s important to have an open discussion with your doctor about switching from Humira, the originator biologic, to a biosimilar like Hyrimoz. Make sure you understand the reasons behind the switch. Your doctor should clearly explain the rationale, and you should feel comfortable asking questions and voicing any concerns.
One factor to consider is the “nocebo effect,” where negative expectations about a treatment can lead to negative outcomes. Your doctor can minimize this by using positive language when discussing Hyrimoz and focusing on its benefits.
Real-World Evidence and Case Studies
Real-world studies have examined the effects of switching from Humira to adalimumab biosimilars, and you can ask your doctor to discuss the findings. For example, a nationwide switching program in Iceland showed some challenges with switching to the biosimilar Imraldi, partly due to differences in the injection devices and injection discomfort.
Regardless of the data, it’s crucial for your doctor to closely monitor you after the switch to assess how well Hyrimoz is working and to watch for any potential side effects.
Managing Patient Expectations
Clear and open communication with your doctor is key to managing your expectations about the switch. Make sure you understand what a biosimilar is and why the switch is being recommended. Talk about any worries you have regarding Hyrimoz’s effectiveness, safety, or how easy the injection device is to use. Some patients find certain biosimilar devices trickier to use, so personalized instruction is really important.
Drug Interactions and Contraindications
Like any medication, Humira and Hyrimoz can potentially interact with other drugs you’re taking, including live vaccines. It’s also possible that you might have a contraindication that would rule out either of these drugs as a treatment option for you.
Potential drug interactions
It’s essential that you tell your healthcare provider about all the medications, supplements, and over-the-counter remedies you’re taking so that they can check for potential interactions.
Contraindications
If you have an active infection, you likely won’t be able to start on Humira or Hyrimoz until the infection has cleared. Also, some biosimilar devices contain latex, which could be a problem if you have a latex allergy.
Frequently Asked Questions
What is the rating of Hyrimoz?
Hyrimoz, like other biosimilars, doesn’t have a “rating” in the same way a movie might. Instead, its approval by regulatory bodies like the FDA and EMA signifies it meets rigorous standards for safety and effectiveness, demonstrating it’s highly similar to Humira with no clinically meaningful differences. Think of it more as a “meets all requirements” seal of approval rather than a numerical rating.
How fast does Hyrimoz work?
The speed at which Hyrimoz starts working varies from person to person and depends on the condition it’s treating. Some people may experience noticeable improvements within a few weeks, while for others, it may take several months to see the full effects. It’s important to stick with your prescribed treatment plan and discuss any concerns or lack of progress with your doctor.
How long has Hyrimoz been around?
Hyrimoz was first approved by the European Medicines Agency (EMA) in 2018. It gained approval from the U.S. Food and Drug Administration (FDA) later, becoming available in the US market in 2023. So, while it’s a relatively newer option compared to Humira, it has several years of real-world use and monitoring behind it, particularly in Europe.
Putting It All Together
Humira and Hyrimoz are very similar medications. Hyrimoz is a biosimilar to Humira, which means it’s designed to work in the same way and have the same effects in your body. Studies have shown that Hyrimoz is as safe and effective as Humira for treating a range of conditions.
When deciding whether to use Humira or Hyrimoz (or another biosimilar), the best choice depends on your individual needs and preferences. Factors like cost, insurance coverage, and how often you need to inject the medication can all play a role.
Good communication between you and your doctor is essential for successful treatment. Talk openly with your doctor about any concerns you have, including potential side effects, how the medication fits into your lifestyle, and what you can expect during treatment. Your doctor can help you weigh the pros and cons of each option and make an informed decision that’s right for you.
Whether you’re using Humira or Hyrimoz, be sure to report any side effects or other concerns to your healthcare provider right away. By working together, you and your doctor can ensure you receive the best possible care and achieve the best possible outcomes.