OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® […]
STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2] The FDA approval is based on robust clinical evidence, which show no clinically […]
AVTOZMA® will be available as both intravenous (IV) and subcutaneous (SC) formulations with the same formulations and dosages as the reference product Approval was received for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), […]
Celltrion unveils strategic roadmap for the first time outlining its innovative drug development strategy and its plan to submit 13 Investigational New Drug (IND) application by 2028 Company reinforces its commitment to a two-pillar growth […]
