/PRNewswire/ Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA).
/PRNewswire/ Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA).
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RIDGEFIELD, Conn., April 23, 2021 /PRNewswire/ Boehringer Ingelheim today announced results from a phase III, randomized study that concluded that switching several times from Humira® (adalimumab) to Cyltezo® (adalimumab-adbm) produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate-to-severe chronic plaque psoriasis. The 32-week data will be presented at the American Academy of Dermatology 2021 virtual meeting experience. We are proud to present the results from Voltaire-X, a landmark study that supports Boehringer Ingelheim s application for interchangeability between Cyltezo® and Humira®, said Thomas Seck, Senior Vice President, Medicine and Regulatory Affairs at Boehringer Ingelheim. This first-of-its-kind switching study further reinforces our goal to broaden access to biosimilar treatment options while contributing to the quality and sustainability of healt