Wezlana is the first biosimilar to reference Stelara approved in the United States. The product will launch in 2025. FDA has approved the first ustekinumab (Stelara) biosimilar in the United States.

A U.S. Marine Corps MV-22 Osprey lands aboard the Royal Australian Navy landing helicopter dock HMAS Canberra during the Rim of the Pacific exercise in 2022. (Leading Seaman Matthew Lyall/Royal ...

Credit: Celltrion. The FDA originally approved Stoboclo and Osenvelt as biosimilars in March 2025. The interchangeability designation allows Stoboclo and Osenvelt to be substituted at the pharmacy for ...

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. In 2009, Congress created a regulatory pathway for ...

Please provide your email address to receive an email when new articles are posted on . Celltrion’s Yuflyma is a high concentration, citrate-free formulation of adalimumab. It is the ninth Humira ...

Basic components designed for single-use in bioprocessing aren’t as interchangeable as biomanufacturers often assume. Subtle differences in components contribute to greater process variability, ...

Knock-off versions of biotech drugs have been on the market for several years now, but one way that the US market for biosimilars has lagged behind its European counterpart is on the question of ...