Author Archives: Ana de Barros PhD

Cyltezo, a Humira Biosimilar, Receives Positive Opinion from European CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cyltezo, a Humira (adalimumab) biosimilar, for the treatment of multiple chronic inflammatory diseases, including severe active ankylosing spondylitis (AS). The maker of Cyltezo, Boehringer Ingelheim, submitted a marketing…

Renflexis, a Remicade Biosimilar, Is Now Available in the US

Renflexis (infliximab-abda), a biosimilar of Remicade (infliximab), is now available in the United States for the treatment of ankylosing spondylitis and other conditions. The launch was recently announced by Samsung Bioepis as the company’s first biosimilar approved in the U.S. Renflexis was approved by the U.S. Food and Drug Administration (FDA) in…