Third Humira Biosimilar Is Approved by FDA

Alvotech’s Simlandi (adalimumab-ryvk) has been approved by the U.S. Food and Drug Administration (FDA) as the third interchangeable Humira biosimilar, joining Pfizer’s Abrilada (adalimumab-afzb) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). Interchangeability means the biosimilar can be substituted for the reference product or another biosimilar at the pharmacy level, although state-level pharmacy regulations can complicate matters. A total of nine Humira biosimilars are on the market in the U.S., so Alvotech’s Simlandi will be the 10th.

“The approval of Simlandi marks the first high-concentration, citrate-free biosimilar to Humira with [interchangeability] status,” said Eric Hughes, MD, PhD, executive vice president of global research and development and chief medical officer at Teva. “Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on seven biosimilars and expand the availability, access and uptake of biosimilars in the U.S.”