EMA’a Cyltezo® approval follows FDA’s green light in September.
Boehringer Ingelheim announced that the European Medicines Agency (EMU) has approved Cyltezo® its version of adalimumab, which physicians prescribe for multiple chronic inflammatory diseases in adults. This includes Rheumatoid Arthritis, Crohn’s disease, psoriasis and other immunological system disorders associated with inflammation.
Boehringer stated that Cyltezo® has also been granted marketing authorization to treat other inflammatory diseases, including in children as young as four years old. However, the biologic is not currently commercially available, and will not be until after adalimumab’s SPC expires in October 2018.
According to Boehringer, the marketing approval of Cyltezo was based on a data package that supported the monoclonal antibody-based medicine’s biosimilarity to Humira® “comprising analytical, pharmacological, non-clinical and clinical data.” These results included Phase III study VOLTAIR-RA, which demonstrated the biosimilar’s clinical equivalence in efficacy and ability to meet its primary endpoint.
Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim, explained, “Cyltezo® is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases.” He continued, adding that the company has applied its expertise to the development of the new biosimilar. “We believe biosimilars will be a key contributor