A 5th Biosimilar Is Approved for Humira

Humira is a specialty medication that helps many people living with chronic conditions like rheumatoid arthritis. It was also the top-selling prescription drug of 2018.

Humira is considered a biologic. That means that it’s made from living cells and has a complex structure. Because of that, there are no substitute generics like there are for brand drugs. Instead, there are biosimilars. Biosimilars are very similar to the biologic drug. They are usually just as effective but are not interchangeable.

The FDA recently approved Abrilada, the 5th biosimilar for Humira. The 1st biosimilar was approved over 3 years ago, but none have been made available to patients yet because of the FDA’s patent laws. Once Abrilada and the other biosimilars are available, they will be considered alternative therapies and be available at a lower cost than Humira.

What is Humira for?

Humira can treat the following conditions:

• Rheumatoid arthritis: A chronic inflammatory disorder

• Plaque psoriasis: An autoimmune condition affecting the skin

• Crohn’s disease: An inflammatory bowel disease

• Pediatric Crohn’s disease: Crohn’s disease in children

• Ulcerative colitis: An inflammatory bowel disease

• Psoriatic arthritis: A type of inflammatory arthritis

• Hidradenitis suppurativa: A chronic skin condition

• Anklyosing spondylitis: A form of arthritis that affects the spine

• Juvenile idiopathic arthritis: A common type of arthritis in children

• Non-infectious uveitis: A form of eye inflammation

How does Humira work?

Humira works by targeting and blocking a protein in the body called tumor necrosis factor (TNF). In large amounts, TNF can cause inflammation and swelling. Humira can help block TNF and decrease the damage caused by these conditions.

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What is Abrilada for?

Abrilada is approved for 7 of the 10 conditions that Humira treats. Unlike Humira, Abrilada is not for uveitis, hidradenitis suppurativa, or pediatric Crohn’s disease.

What are the other Humira biosimilars?

These are all Humira biosimilars and their approval date:

• Amjevita, September 2016

• Cyltezo, August 2017

• Hyrimoz, October 2018

• Hadlima, July 2019

• Abrilada, November 2019

When will the biosimilars be available?

Abbvie, the manufacturer of Humira, has a patent on Humira. This means that the biosimilars for Humira can’t be launched until the patent expires. These biosimilars, including Abrilada, won’t be available in the U.S. until 2023.

How much will Abrilada cost?

Cost information on Abrilada is not yet available, but biosimilars are generally 15% to 30% cheaper than the biologics.

To learn more, you can read Pfizer’s press release here.

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Written by:

Ronilee Shye, PharmD, BCGP, BCACP, CDE

Roni is an expert in clinical pharmacy and patient care. She received her doctorate in pharmacy from Duquesne University in Pittsburgh, Pennsylvania; is board-certified in geriatrics and ambulatory care pharmacy; and is licensed to practice pharmacy in Ohio, Pennsylvania, and Florida.

Edited by:

Tori Marsh, MPH

Tori Marsh is GoodRx’s resident expert on prescription drug pricing, prescribing trends, and drug savings. She oversees the GoodRx drug database, ensuring that all drug information is accurate and up to date.

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