Bio-Thera Solutions, Hikma get FDA nod for generic Stelara
Bio-Thera Solutions and Hikma have obtained the Food and Drug Administration’s permission for Starjemza (ustekinumab-hmny) Injection, a biosimilar of Janssens’ Stelara (ustekinumab) Injection.
Bio-Thera and Hikma entered into a license and commercialization agreement for Starjemza in August 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product, while Hikma is responsible for the commercialization of Starjemza in the United States.
"The approval of Starjemza is another significant accomplishment for Bio-Thera, establishing Bio-Thera as a premier global biosimilar developer and manufacturer," said Shengfeng Li, CEO at Bio-Thera. "As our third FDA approved biosimilar, Starjemza demonstrates Bio-Thera's commitment to developing more biosimilars, expanding patient access to important therapies."
[Read more: Hikma gets FDA nod for generic Victoza, launches 2 new generics]
"This approval and our partnership with Bio-Thera enables us to strongly enter the U.S. biosimilar market, building on our well-established position as a top-three domestic provider of sterile injectable medicines to U.S. hospitals, healthcare providers, and patients," said Dr. Bill Larkins, president of Hikma Injectables.
Larkins added, "Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it."
[Read more: Hikma acquires Novugen’s FDA-approved ANDA for generic Mekinist]