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Samsung Bioepis’ Herceptin biosimilar received final European approval

Samsung Bioepis Co., Ltd. announced the European Commission’s (EC) marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic ...

Samsung Bioepis first to receive EC approval for its third anti-TNF biosimilar

Samsung Bioepis Co., Ltd. last week announced the European Commission’s (EC) approval of Imraldi, a biosimilar referencing Humira (adalimumab). Imraldi is approved for the treatment of rheumatoid ...

Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe

Sandoz, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz’ biosimilar rituximab and biosimilar ...

Mylan and Biocon filed the biosimilar Herceptin application to FDA

Mylan N.V. and Biocon Ltd. last week announced submission of Mylan’s biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) ...
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