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.e60dc2a1-f33c-4a05-9b50-8e3e8e59762952801d1d-8329-4555-99ca-30cde67d135ee60dc2a1-f33c-4a05-9b50-8e3e8e59762943bcaccc-61d5-480e-9fbf-d88c0ca3b7fe 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.e60dc2a1-f33c-4a05-9b50-8e3e8e59762943bcaccc-61d5-480e-9fbf-d88c0ca3b7fe
What Are Biosimilars? Definition 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.e60dc2a1-f33c-4a05-9b50-8e3e8e597629cca7d422-20a4-4a6d-9bb6-9a8a8152797d 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.e60dc2a1-f33c-4a05-9b50-8e3e8e597629cca7d422-20a4-4a6d-9bb6-9a8a8152797d 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).e60dc2a1-f33c-4a05-9b50-8e3e8e5976291d937964-f18e-4a6e-93ce-c34fc6dfd30e
List of Biosimilars for Treating Ulcerative Colitis List 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:e60dc2a1-f33c-4a05-9b50-8e3e8e597629a9c1e22c-d7d2-4098-8ac7-4b72ab2d67b1 Humira (adalimumab) Remicade (infliximab) Stelara (ustekinumab) Humira Biosimilars UC treatments that are considered biosimilars of Humira include:e60dc2a1-f33c-4a05-9b50-8e3e8e597629a9c1e22c-d7d2-4098-8ac7-4b72ab2d67b1 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:e60dc2a1-f33c-4a05-9b50-8e3e8e597629a9c1e22c-d7d2-4098-8ac7-4b72ab2d67b1 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:e60dc2a1-f33c-4a05-9b50-8e3e8e597629a9c1e22c-d7d2-4098-8ac7-4b72ab2d67b1 ustekinumab-srlf (Imuldosa) ustekinumab-aauz (Otulfi) ustekinumab-ttwe (Pyzchiva) ustekinumab-aekn (Selarsdi) ustekinumab-auub (Wezlana) ustekinumab-kfce (Yesintek)
Side Effects of UC Biosimilars Side Effects 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.e60dc2a1-f33c-4a05-9b50-8e3e8e5976294d0178c4-4587-4aff-bccd-ab8d5844000a Humira Side Effects Common side effects of Humira include:e60dc2a1-f33c-4a05-9b50-8e3e8e597629196f142c-b065-4da1-8730-c5e9542ac7b4 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:e60dc2a1-f33c-4a05-9b50-8e3e8e5976298b442a1c-f848-4c09-99e4-6bbf649415a9 Respiratory infections or sinus infections Sore throat Coughing Headache Stomach pain Stelara Side Effects Common side effects of Stelara include:e60dc2a1-f33c-4a05-9b50-8e3e8e597629d52302fe-6d93-40c9-9676-2b44f7fc83b4 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.
Resources We Trust Mayo Clinic: Advances in the Treatment of Crohn’s Disease and Ulcerative ColitisCleveland Clinic: Biosimilar Safety and Efficacy Comparable to Biologic Treatment in IBD PatientsCrohn’s and Colitis Foundation: IBD MedicationU.S. Food and Drug Administration: Biosimilar Product InformationThe University of Chicago: Biologics and Inflammatory Bowel Disease (IBD)
Additional reporting by Ashley Welch .
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