A 2022 Recap of Biosimilar Approvals in the U.S.

New medical treatments often act as a new or refreshed source of hope. Perhaps it’s an innovative medication that’s more effective than previous treatments. Or, maybe it’s a medication that has fewer side effects than previous ones. A more accessible or affordable medication can also make headlines.

Biosimilar drug approvals fall into the latter category. Biologic medications are complex medications that come from living sources, and they’re often prescribed for hard-to-treat health conditions. However, they can come with an elevated price tag. Biosimilars are a subgroup of biologics that tend to be more accessible — yet similarly safe and effective — alternatives to other biologics.

Here, we’ll review biosimilar medications that were FDA approved or made headlines in 2022.

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What biosimilars were approved in 2022?

Biosimilars are “highly similar” to their reference (original) biologic medication. Some people like to think of them as generic versions of brand-name biologics. So if you or a loved one need a biologic medication and a biosimilar is available, your healthcare provider may opt to prescribe the biosimilar for value’s sake.

The FDA has approved 40 biosimilar drugs since 2015. Of those, seven were approved in 2022.

1. Alymsys, a biosimilar to Avastin

Avastin (bevacizumab) is a common cancer medication. Injected into your vein once every 2 to 3 weeks, it’s a treatment option for colorectal cancer, lung cancer, cervical cancer, and more. It also has several biosimilars. What’s more, out of all biosimilars, Avastin’s biosimilars have seen the largest uptick in use.

One of Avastin’s biosimilars is Alymsys (bevacizumab-maly). It was FDA approved and launched in the U.S. in 2022 as the third Avastin biosimilar to come to market. It can treat all of the same types of cancer as Avastin — except for liver cancer.

2. Vegzelma, a biosimilar to Avastin

Vegzelma (bevacizumab-adcd) is the fourth and most recent Avastin biosimilar. It was approved in September 2022, and it should be available in the U.S. sometime during the first half of 2023.

After it’s shipped and distributed, your cancer center may opt to give you Vegzelma, Alymsys, or another biosimilar instead of Avastin. This decision will come down to what your cancer center has in stock, what your insurance plan’s preferred product is (if applicable), and your healthcare provider’s preferences.

3. Releuko, a biosimilar to Neupogen

Releuko (filgrastim-ayow) was the first biosimilar approved in 2022. It’s a biosimilar to Neupogen (filgrastim).

Neupogen, Releuko, and other Neupogen biosimilars are injectable medications that help increase your white blood cell counts. This is helpful if you’re receiving certain types of chemotherapy for cancer treatment. If your white blood cell (neutrophil) counts drop too low, you have a higher risk for infection and other complications.

4. Fylnetra, a biosimilar to Neulasta

Fylnetra (pegfilgrastim-pbbk) is one of Neulasta’s biosimilars. It was approved in May 2022 as the fifth Neulasta (pegfilgrastim) biosimilar. It was commercially launched soon after.

Compared to Neupogen, Neulasta is like a longer-lasting cousin. They’re used for similar reasons, but Neulasta is administered less frequently. Neupogen is injected or infused daily, but Neulasta is given as a one-time injection during each chemotherapy cycle.

5. Stimufend, a biosimilar to Neulasta

Stimufend (pegfilgrastim-fpgk) is the sixth and most recent biosimilar to Neulasta. It was approved in September 2022; it’s reportedly expected to launch over the coming months.

Like Neulasta and other Neulasta biosimilars, Stimufend is given as an under-the-skin (subcutaneous) injection. It’s not injected into a vein.

6. Cimerli, a biosimilar to Lucentis

Lucentis (ranibizumab) is a biologic eye medication. It’s injected into the eye and treats five vision-threatening health conditions:

• Wet age-related macular degeneration

• Diabetic macular edema

• Diabetic retinopathy

• Macular edema due to a blood clot in the eye

• Myopic choroidal neovascularization

Cimerli (ranibizumab-eqrn) is the second biosimilar to Lucentis, following in the footsteps of Byooviz (ranibizumab-nuna). Cimerli was approved in August 2022 and launched soon after. However, unlike Byooviz, Cimerli is approved to treat all five of the same health conditions as Lucentis.

What’s more, Cimerli is also an interchangeable biosimilar. More on this later.

7. Idacio, a biosimilar to Humira

Humira (adalimumab) is preparing to face the most biosimilar competition out of all biologic medications. Eight Humira biosimilars are now approved, and they’re all set to launch throughout 2023.

Idacio (adalimumab-aacf) is the eighth and most recent one. It was approved in December 2022 as another treatment option for rheumatoid arthritis, Crohn’s disease, and five other autoimmune disorders.

Idacio should launch in the U.S. sometime after July 1, 2023.

What interchangeable biosimilars were approved in 2022?

Not all biosimilars are studied equally. Some of them have extra data to show they’re interchangeable with their reference biologic. These are called interchangeable biosimilars. You can expect to switch back and forth between these products without issue.

Interchangeable biosimilars are useful at the community pharmacy. Depending on your state, your pharmacist has the authority to give you an interchangeable biosimilar in place of a reference biologic. They can do this without contacting your prescriber for approval first. Interchangeable biosimilars are handy at hospitals and health clinics, too.

Rezvoglar, an interchangeable biosimilar to Lantus

If your healthcare provider gives you a prescription for Lantus (insulin glargine), your pharmacy could dispense Rezvoglar (insulin glargine-aglr) instead. Rezvoglar was initially approved in 2021, but it became an interchangeable biosimilar in November 2022. It’s an equally effective, long-acting insulin product that can help manage diabetes.

Cimerli, an interchangeable biosimilar to Lucentis

As mentioned, Cimerli is interchangeable with Lucentis. Your ophthalmologist could decide to give you Lucentis and then give you Cimerli at a later date (or vice versa). Available data shows that you shouldn’t encounter any additional risks or effectiveness changes when switching between the two products.

What biosimilars could be approved in 2023?

Many more biosimilars are expected to be approved in the next decade and beyond. Keep an eye out for these potential approvals in 2023:

• A biosimilar to Simponi (golimumab), an injection that treats several autoimmune disorders

• A biosimilar to Tysabri (natalizumab), an infusion that treats multiple sclerosis and Crohn’s disease

• Biosimilar(s) to Actemra (tocilizumab), an infusion and injection that treats several autoimmune disorders

• Biosimilar(s) to Eylea (aflibercept), an eye injection that’s comparable to Lucentis

• Biosimilar(s) to NovoLog (insulin aspart), a fast-acting insulin for diabetes

• Biosimilar(s) to Soliris (eculizumab), an infusion that treats rare blood and nerve disorders

• Biosimilar(s) to Stelara (ustekinumab), an injection used for different types of psoriasis and inflammatory bowel disease

Why trust our experts?

Written 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:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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