Boehringer Ingelheim’s First Biosimilar Is Approved in Europe

Boehringer Ingelheim (BI) announced today that it received marketing authorization in Europe for Cyltezo®, which is a biosimilar to Humira®.  Cyltezo® was approved for the treatment of multiple chronic inflammatory diseases in adults and children.  As previously reported, BI’s Cyltezo® was approved by the FDA on August 25, 2017, and is the subject of ongoing patent litigation in the U.S. District Court for the District of Delaware.  According to BI, Cyltezo® is not commercially available in Europe or the U.S. at this time, and BI does not intend to launch Cyltezo® in the European Union before the expiration of the supplementary protection certificate for adalimumab in October 2018.