Trastuzumab Biosimilars: What to Know About Ogivri and Other Herceptin Alternatives

Herceptin (trastuzumab) is a widely-used biologic medication. It treats certain types of HER2-positive cancer, including breast cancer and gastric (stomach) cancer. Over the years, it has become a standard treatment for many people living with HER2-positive cancer. So in an effort to make this highly-touted treatment more accessible, five trastuzumab biosimilars have been approved in the U.S. since 2017.

If you or a loved one have been diagnosed with a HER2-positive cancer, Herceptin or a trastuzumab biosimilar may be a treatment option for you. But what is a biosimilar? And how do they stack up to Herceptin?

What is trastuzumab?

Herceptin, also known as trastuzumab, is an injectable biologic medication. Biologics are complex medications that are produced from living or natural resources, such as bacteria, proteins, or sugars. Herceptin is typically given as an intravenous (IV) infusion every 1 to 3 weeks, and you can receive it by itself or in combination with chemotherapy.

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After it’s infused, Herceptin fights cancer in a specific way. It’s a targeted therapy medication known as a human epidermal growth factor receptor 2 (HER2) blocker. HER2 is a protein that helps cancer cells grow rapidly. By targeting and blocking HER2, Herceptin tells cancer cells to stop growing. Cancers that have a higher amount of HER2 receptors (chemical binding sites) are called “HER2-positive.”

Due to how it works, Herceptin is approved to treat certain types of HER2-positive breast cancer and HER2-positive stomach cancer. It may also be used off-label for other types of cancer, like HER2-positive endometrial cancer or colorectal cancer.

Herceptin vs. Herceptin biosimilars

Herceptin was initially approved in 1998 for metastatic HER2-positive breast cancer. Since then, it has helped enhance the treatments of many people living with HER2-positive cancer. However, the need for more affordable treatment options for HER2-positive cancer has only grown.

That's where trastuzumab biosimilars come in. Biosimilars are a type of biologic medication that are highly similar to their original (reference) biologic. You can expect them to work the same way as their original biologic, and have similar side effects. But they often come with a lower price tag.

In various studies, the five trastuzumab biosimilars have proven to be comparable to their original biologic: Herceptin. All trastuzumab biosimilars are approved to treat the same cancers as Herceptin, and they also have the same dosages.

Note: Herceptin Hylecta (trastuzumab/hyaluronidase) is another form of trastuzumab that’s administered subcutaneously (under the skin). Trastuzumab biosimilars are only biosimilar to Herceptin, not Herceptin Hylecta.

Let’s look at each biosimilar a little more closely. 

1. Ogivri

In December 2017, Ogivri (trastuzumab-dkst) became the first trastuzumab biosimilar to be approved. Like Herceptin, it’s approved to treat HER2-positive breast and stomach cancer. Clinical studies show that Ogivri's safety and effectiveness is comparable to Herceptin.

For instance, Ogivri was compared to Herceptin in combination with chemotherapy in a study of people with HER2-positive breast cancer. People who received Ogivri had a response rate of about 70%, meaning 70% of people saw their cancer shrink or disappear. Those who received Herceptin had a similar response rate. Other studies, like lab studies, also confirm there’s no clinically meaningful differences between the two.

However, some differences between Ogivri and Herceptin do exist. Ogivri is formulated with inactive ingredients that differ from Herceptin. It contains PEG 3350 and sorbitol, while Herceptin and the other approved trastuzumab biosimilars do not. If you’re scheduled to receive multiple medications at the clinic, these inactive ingredients could slightly impact the timing of your infusions on your appointment day.

2. Herzuma

Herzuma (trastuzumab-pkrb) was the second approved trastuzumab biosimilar. It was approved  in December 2018.

Like Ogivri, Herzuma was compared to Herceptin in combination with chemotherapy in a clinical trial of people with HER2-positive breast cancer. In this study, people who received Herzuma had a pathologic complete response rate of about 47%. People receiving Herceptin had similar results. Herzuma and Herceptin were found to be comparably safe and effective.

Note: A pathologic complete response means that there were no remaining signs of cancer found in surgically-removed tissue.

3. Ontruzant

Ontruzant (trastuzumab-dttb) is the third Herceptin biosimilar. It was approved shortly after Herzuma in January 2019.

One key study compared Ontruzant to Herceptin in people with early-stage HER2-positive breast cancer. People receiving Ontruzant in combination with chemotherapy had a pathologic complete response of about 52%. This was similar to people who received Herceptin.

4. Trazimera

Trazimera (trastuzumab-qyyp) became the fourth approved Herceptin biosimilar in March 2019. 

Trazimera is backed by similar data. One study compared it to Herceptin in combination with chemotherapy in people with metastatic HER2-positive breast cancer. People who received Trazimera had a response rate of about 63%, which was similar to Herceptin.

5. Kanjinti

The fifth and most recent Herceptin biosimilar to gain approval in the U.S. was Kanjinti (trastuzumab-anns). The FDA approved it in June 2019.

Kanjinti was compared to Herceptin in a clinical trial of people with early HER2-positive breast cancer. People who received Kanjinti had a pathologic complete response rate of 48%. Like the other studies, people who received Herceptin had a similar response.

Kanjinti is also the only trastuzumab biosimilar that has transition study data available. This means that Kanjinti was studied in people who were receiving Herceptin and then switched their treatment to Kanjinti. This study found that it was safe to switch back and forth between the two medications.

Your healthcare provider may decide to give you Kanjinti, Herceptin, or another trastuzumab biosimilar. But, it’s important to note that none of the trastuzumab biosimilars have technically been deemed interchangeable biosimilars.

How to choose the best trastuzumab biosimilar

Trastuzumab biosimilars haven’t been directly compared to each other, so we don’t know if one is better than another. But based on how they’re made, it isn’t expected for there to be any clinically meaningful differences between them.

What’s available at your cancer center — and your expected out-of-pocket costs — will help determine which trastuzumab biosimilar you’ll receive. Your cancer center may stock all, some, or one of the trastuzumab biosimilars on their formulary. Your health insurance may also prefer to cover Herceptin itself, one biosimilar product specifically, or some combination of the two. Most insurance plans cover at least one Herceptin biosimilar.

If you’re uninsured or underinsured, there may be other ways to save. Manufacturer savings programs are one example. Some of these programs for Herceptin and its biosimilars are the Teva Shared Solutions for Biosimilars, Amgen’s Assist360, and Pfizer Oncology Co-pay Savings Program. The savings program you qualify for may help determine which product you’ll get.

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Written by:

Sonja Jacobsen, PharmD, BCPS, BCOP

Sonja Jacobsen, PharmD, BCPS, BCOP,  is a clinical oncology pharmacy specialist currently practicing in Seattle. She has been practicing as a pharmacist since 2015 and is licensed to practice in Washington state and North Carolina.

Edited by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

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