Biosimilars Approved for Inflammatory Bowel Diseases

Medically Reviewed

People with inflammatory bowel disease (IBD) may have new options for treatment. The FDA has approved the first biosimilar drugs to treat moderate to severe Crohn’s disease and ulcerative colitis in patients for whom conventional therapy has been inadequate.

The new medications are Inflectra, a biosimilar for Remicade (infliximab); Erelzi, a biosimilar for Enbrel (etanercept); and Amjevita, a biosimilar for Humira (adalimumab).

Administered by intravenous infusion, the new drugs are tumor necrosis factor inhibitors (TNFi), acting directly on the immune system by blocking the production of excess amounts of inflammatory proteins.

Research has found the new drugs to have the same safety, efficacy, and tolerability profile as the original drugs.

The new biosimilars share the same potential side effects, most commonly respiratory infections, coughing, headache, stomach pain, and infusion-related reactions that can occur up to two hours after a patient receives the treatment.

The drugs also increases the risk of serious infection, such as tuberculosis or bacterial sepsis, that can lead to hospitalization or death.

If you are considering modifying your treatment plan, speak with your doctor to find out if a biosimilar may be right for you. It is not yet clear when the biosimilars will become available in pharmacies or how much they will cost.