Credit: FDA. The approval was based on data from a phase 1 study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of Hadlima 100mg/mL to 50mg/mL. The Food and Drug ...
Samsung Bioepis and Organon shared that the Food and Drug Administration has designated the Hadlima (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 ml, 40 mg/0.8 ml) autoinjectors and ...
“This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no ...
LONDON, Sept. 17, 2019 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable Moody's and BB+/positive S&P) the multinational ...
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 ...
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