The U.S. Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals’ Cyltezo (adalimumab) for the treatment of multiple chronic inflammatory diseases.
Cyltezo is the first biosimilar – that is, a biologic medical product that is almost an identical copy of an original product manufactured by a different company, in this case AbbVie’s Humira – from Boehringer Ingelheim to be approved by the FDA.
The FDA approval is based on a comprehensive data package composed of analytical, pharmacological, nonclinical and clinical development studies demonstrating that Cyltezo is biosimilar to Humira. The European Medicines Agency is expected to provide an opinion on the marketing authorization application for Cyltezo later this year.
With Ridgefield-based Boehringer Ingelheim engaged in patent litigation with AbbVie, Cyltezo is not yet commercially available. The drug is designed to be administered subcutaneously via a pre-filled syringe.
Among the diseases that Cyltezo is meant to treat are moderate to severe active rheumatoid arthritis, psoriatic arthritis, adult Crohn’s disease and ulcerative colitis.
Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., the company said.