FDA Approves Interchangeable Biosimilar for Inflammatory Diseases

FDA recently approved Boehringer Ingelheim’s Cyltezo as the first interchangeable biosimilar product to treat certain inflammatory diseases.

Specifically, the agency approved the drug for severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderate to severely active Crohn’s disease, moderate to severely active ulcerative colitis, and moderate to severe chronic plaque psoriasis. 

The agency first approved Cyltezo in August 2017 as a biosimilar to Humira for multiple chronic inflammatory diseases. 

Cyltezo is the second interchangeable product that the FDA has approved and the first interchangeable monoclonal antibody. With the recent approval, Cyltezo is now both biosimilar to and interchangeable with Humira.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement. 

“We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective,” Woodcock continued. 

Physicians will administer Cyltezo as a single-dose, pre-filled syringe to patients infected with one of the intended inflammatory or chronic diseases listed.   

Like Humira, Cyltezo comes with a boxed warning about the increased risk of severe infections and potentially fatal cancers in children and adolescents treated with the drug. 

Once on the market, interchangeable biosimilar products can help facilitate access to treatments for various health conditions without changing the prescription. 

Overall, experts believe biosimilars are a viable solution for rising drug costs as long as the industry fosters competition. Recent research found that biosimilars may reduce direct spending on biologic drugs by $54 billion from 2017 to 2026.

In July 2021, FDA approved Mylan’s interchangeable biosimilar insulin product, Semglee, to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. 

And in September, FDA approved Samsung Bioepis and Biogen’s Byooviz as the first biosimilar to Lucentis to treat several eye diseases and conditions.