Biosimilar Drugs for Ulcerative Colitis: Everything You Need to Know
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Biosimilar Drugs for Ulcerative Colitis: Everything You Need to Know

Biosimilar Drugs for Ulcerative Colitis: Everything You Need to Know
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Updated on August 25, 2025
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Since the late 1990s, multiple biologic drugs have been approved to help people with ulcerative colitis (UC) and Crohn’s disease achieve and maintain remission. This includes biosimilars, which are copies of existing drugs that may be less expensive than the original version.

Biosimilars are considered to be just as effective and safe as the drugs they’re based on. Here’s what you should know about biosimilars and how they’re used to treat UC.

What Are Biosimilars?

Biosimilars aren’t exact copies of the drugs they’re based on. But in order to be approved, manufacturers need to demonstrate that biosimilars have no clinically meaningful differences from the reference product in terms of potency, purity, and safety.

Instead of showing that a biosimilar is identical to the original drug on a molecular level, manufacturers must prove that it’s similar enough to the original to have no clinically meaningful difference. This is done through clinical trials for safety and effectiveness.

In 2010, Congress created a pathway for U.S. Food and Drug Administration (FDA) approval of biosimilars as part of the Affordable Care Act. It wasn’t until 2015, though, that the FDA actually approved a biosimilar drug and not until 2016 that it approved a biosimilar drug to treat inflammatory bowel disease (IBD).

List of Biosimilars for Treating Ulcerative Colitis

As of July 2025, there are 21 biosimilar treatments approved for people living with UC, according to the Crohn’s and Colitis Foundation. They are usually based on one of the following drugs:

  • Humira (adalimumab)
  • Remicade (infliximab)
  • Stelara (ustekinumab)

Humira Biosimilars

UC treatments that are considered biosimilars of Humira include:

  • adalimumab-afzb (Abrilada)
  • adalimumab-atto (Amjevita)
  • adalimumab-adbm (Cyltezo)
  • adalimumab-bwwd (Hadlima)
  • adalimumab-fkjp (Hulio)
  • adalimumab-adaz (Hyrimoz)
  • adalimumab-aacf (Idacio)
  • adalimumab-ryvk (Simlandi)
  • adalimumab-aaty (Yuflyma)
  • adalimumab-aqvh (Yusimry)

Remicade Biosimilars

UC treatments that are considered biosimilars of Remicade include:

  • infliximab-axxq (Avsola)
  • infliximab-dyyb (Inflectra)
  • infliximab-qbtx (Ixifi)
  • infliximab-abda (Renflexis)
  • infliximab-dyyb (Zymfentra)

Stelara Biosimilars

UC treatments that are considered biosimilars of Stelara include:

  • ustekinumab-srlf (Imuldosa)
  • ustekinumab-aauz (Otulfi)
  • ustekinumab-ttwe (Pyzchiva)
  • ustekinumab-aekn (Selarsdi)
  • ustekinumab-auub (Wezlana)
  • ustekinumab-kfce (Yesintek)

Side Effects of UC Biosimilars

The side effects of biosimilars for UC are generally similar to those of the drug they’re based on. Talk with your doctor about all possible side effects when considering a change to a biosimilar treatment for UC.

Humira Side Effects

Common side effects of Humira include:

  • Injection site reactions (redness, swelling, pain, bruising)
  • Upper respiratory infections, or sinus infections
  • Headaches
  • Nausea
  • Rash

Remicade Side Effects

Common side effects of Remicade include:

  • Respiratory infections or sinus infections
  • Sore throat
  • Coughing
  • Headache
  • Stomach pain

Stelara Side Effects

Common side effects of Stelara include:

  • Injection site redness
  • Upper respiratory infections
  • Tiredness
  • Headache
  • Vomiting
  • Itching
  • Urinary tract infections
  • Vaginal yeast infections

The Takeaway

  • Biosimilars are near-identical copies of biologic medicines. They may also cost less than the original versions.
  • There are a number of biosimilars available for UC that are based on biologics like adalimumab (Humira), infliximab (Remicade), and ustekinumab (Stelara).
  • Talk to your doctor to learn more about biosimilars and see if they may be a good option for you.

Additional reporting by Ashley Welch.

EDITORIAL SOURCES
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Resources
  1. Actis GC et al. History of Inflammatory Bowel Diseases. Journal of Clinical Medicine. November 14, 2019.
  2. Biosimilars: What You Should Know. Crohn’s and Colitis Foundation.
  3. Biosimilars Info Sheet Level 1: Foundational Concepts. U.S. Food and Drug Administration.
  4. Gherghescu I et al. The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. Pharmaceutics. December 31, 2020.
  5. IBD Medication. Crohn’s and Colitis Foundation.
  6. Biosimilars Basics for Patients. U.S. Food and Drug Administration. August 1, 2024.
  7. Humira. Crohn’s and Colitis Foundation.
  8. Remicade. Crohn’s and Colitis Foundation.
  9. Stelara. Crohn’s and Colitis Foundation.
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