2021 Recap: FDA Biosimilar Approvals

Biosimilar approvals are important because they give people lower-cost options in treating many complex health conditions. That’s because biologics — medications derived from living organisms — are some of the most expensive therapies available today. Biosimilars are highly similar, yet less expensive, versions of biologics.

Since 2015, the FDA has approved over 30 biosimilars. And while some years have had more approvals than others, 2021 was a year of many “firsts.” This includes the first interchangeable biosimilar of Lantus (insulin glargine), a more expensive brand-name insulin product.

Last year, the FDA approved five biosimilars. These include first-time approvals, as well as new  interchangeable designations. Let’s review why they’re important and what’s in store for 2022.

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What biosimilars were approved in 2021?

The FDA approved several new biosimilars in 2021. These include injectable medications used to treat eye conditions, diabetes, and autoimmune disorders.

Byooviz

In September 2021, the FDA approved Byooviz (ranibizumab-nuna) as the first biosimilar eye product. It’s a biosimilar to Lucentis (ranibizumab). 

Byooviz is an injection approved to treat three different eye conditions. These include wet age-related macular degeneration (AMD), retinal vein occlusion (RVO), and myopic choroidal neovascularization (CNV). They’re all caused by damage in the back of the eye (an area called the macula).

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According to the manufacturer, it won’t be available in the U.S. before June 2022. The manufacturer has also yet to announce cost information. But it’ll likely have a lower price than Lucentis. Monthly Lucentis injections cost around $2,000 each.

Rezvoglar 

In December 2021, the FDA approved Rezvoglar (insulin glargine-aglr). It’s the second biosimilar to Lantus. An official launch date has yet to be announced.

Rezvoglar is an injectable long-acting insulin that helps control blood sugar in people with diabetes. It’s approved for use in adults and children with Type 1 diabetes, and for adults with Type 2 diabetes.

The price of Rezvoglar hasn’t been announced yet. But it’s expected to be less expensive than Lantus. The list price for Lantus is about $425 for five injection pens and $280 for one 10 mL vial.

Yusimry

In December 2021, the FDA approved Yusimry (adalimumab-aqvh). It’s the seventh biosimilar to Humira (adalimumab). But because of Humira’s patent protection, it’s expected to launch in the U.S. after July 2023. 

Yusimry is an injectable tumor necrosis factor alpha (TNF-alpha) inhibitor. It’s approved to treat many different autoimmune conditions, including:

• Rheumatoid arthritis

• Juvenile idiopathic arthritis

• Psoriatic arthritis

• Ankylosing spondylitis

• Crohn’s disease

• Ulcerative colitis

• Plaque psoriasis

Humira is one of the most expensive popular brand-name drugs in the U.S. It’s average retail price is $9,000 or higher. And while Yusimry’s price isn’t available right now, it's expected to launch with several other lower-cost Humira biosimilars in 2023. 

What interchangeable biosimilars were approved in 2021?

The FDA also approved the first interchangeable biosimilars in 2021. Interchangeable biosimilars need to meet additional requirements to receive this designation. This designation means that you can switch back and forth between a biosimilar and its reference biologic without issues.

Interchangeable biosimilars can be substituted more easily if the reference biologic is prescribed. In the other words, your pharmacist may be able to make the switch to a biosimilar without contacting your healthcare provider first. This is often done to save you money.

Semglee

In July 2021, Semglee (Insulin glargine-yfgn) made history by becoming the first FDA-approved interchangeable biosimilar. Semglee is also the first insulin product to go through the biosimilar approval pathway. That’s because insulin wasn’t officially considered a biologic until March 2020. Only biologic medications are eligible for the FDA’s biosimilar approval pathway. 

Like Rezvoglar, Semglee is an injectable long-acting insulin. It’s also a biosimilar to Lantus. It’s approved for use in adults and children with Type 1 diabetes, and in adults with Type 2 diabetes. 

Semglee was originally launched in the U.S. in August 2020. But it didn’t get its interchangeable status until 2021. The manufacturer launched both branded and unbranded versions of the interchangeable Semglee in late 2021.

The average retail price of one vial of Semglee is about $125. You can save as much as 13% off this price by using a free GoodRx discount.

Cyltezo

Cyltezo (adalimumab-adbm) was originally approved in 2017. It's one of seven Humira biosimilars. But it became the first and only interchangeable one in October 2021. 

Like Yusimry, Cyltezo is an injectable TNF-alpha inhibitor. It’s also approved to treat the same autoimmune conditions. And it’s expected to launch in July 2023, too. 

Cyltezo’s cost hasn’t been released yet. But it should also be less expensive than Humira.

What biosimilars could be approved in 2022?

Biosimilar approvals have gained a lot of interest over the last few years. In fact, there are several more that we may see approved in 2022. Below are some examples of biosimilars under FDA review.

Herceptin biosimilars

Herceptin (trastuzumab) is an injectable medication used to treat several types of cancer. There are currently at least two Herceptin biosimilars that have open applications with the FDA.

Tanvex Biopharma submitted an application for their biosimilar in October 2021. Also, Sandoz and EirGenix submitted an application for their biosimilar in December 2021. It’s possible the FDA could reach a decision on these applications by late 2022.

Lucentis biosimilars

Coherus BioSciences hopes to follow the approval of Byooviz with their own Lucentis biosimilar in 2022. The company announced their application submission in early October 2021. The FDA is expected to issue a decision by August 2022.

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Written 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.

Reviewed 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.

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