The US Food and Drug Administration (FDA) has granted approval for Celltrion's Avtozma (tocilizumab-anoh) in both intravenous and subcutaneous formulations as an Actemra biosimilar for treating ...

Omlyclo is used for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, ...

Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along ...

On March 3, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; 70 mg/mL injection), referencing Amgen’s ...

Teva and Celltrion’s attempt to muscle in on the ... and Herceptin chipped in with $2.8 billion. Although biosimilars are sold at a discount to the originator drugs, they are not sold at the ...

JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the ... Patients were randomized to receive 300 mg or 150 mg of OMLYCLO or reference product every 4 weeks.

Celltrion announced Tuesday that its biosimilars Stoboclo and Osenvelt, referencing bone disease treatments Prolia and Xgeva (denosumab), have received marketing approval from the US Food and Drug ...

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion today announced that the ... Data showed that Eydenzelt ® (40 mg/mL solution for injection in vial and pre-filled syringe), Stoboclo ® (60 ...

The FDA has approved Celltrion’s Omlyclo (omalizumab-igec), the first and ... All patients were randomly assigned to receive either Omlyclo in 300 mg or 150 mg doses or Xolair every four weeks for up ...