Brazil Approves Yesintek as a Stelara Biosimilar for Autoimmune Diseases

Overview

• Anvisa published the Yesintek registration Monday in the government gazette under Resolution 1,896/2026 after a comparability review to Stelara required by RDC 55/2010.
• The ustequinumab drug is cleared for plaque psoriasis in adults and children 6 and older, for active psoriatic arthritis, and for moderate to severe Crohn’s disease and ulcerative colitis in adults who did not respond to prior therapy or could not tolerate it, including anti‑TNF drugs.
• Regulators describe Yesintek as a biosimilar, meaning tests showed similar quality, safety, and efficacy to the reference biologic rather than an identical copy like a generic.
• The product will be sold as ready‑to‑use injections for under‑the‑skin use and for intravenous infusion, matching common routes for these conditions.
• No launch date, price, or adoption by Brazil’s public health system was announced, so real‑world access will hinge on the maker’s rollout and on buyer decisions in public and private plans.