FDA Approves High-Concentration YUSIMRY, a Humira Biosimilar
The FDA has approved a high-concentration formulation of YUSIMRY (adalimumab-aqvh), a biosimilar to Humira. Meitheal Pharmaceuticals said the citrate-free formulation is approved as interchangeable with Humira for nine indications.
The decision gives Chicago-based Meitheal approval for both low- and high-concentration versions of YUSIMRY. The company said the high-concentration version is available in an autoinjector. Its low-concentration version is available in an autoinjector and a prefilled syringe.
Emerge Bioscience holds the approved biologics license application for YUSIMRY. Under a licensing agreement with Emerge, Meitheal is the product’s U.S. regulatory agent and has exclusive U.S. commercialization rights.
Adalimumab is used to treat several chronic inflammatory diseases. An interchangeable designation allows a biosimilar to be substituted for its reference product, subject to applicable pharmacy laws. The approval covers the nine Humira indications for which YUSIMRY is approved, according to Meitheal.
The approval follows the FDA’s July 2026 approval of Garzulys (insulin aspart-fsan) injection, another product in Meitheal’s biologics business. Meitheal’s parent company, Hong Kong King-Friend Industrial, has supported its biologics operations through capital and research investments, the company said.
Meitheal reported more than $500 million in capital and research and development investments, including $30 million for a monoclonal antibody drug-substance facility.
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