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FDA Approves Ogivri, the First Biosimilar for Treatment of Certain Breast and Stomach Cancers

09:42 EST 4 Dec 2017 | Speciality Pharma Journal

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Dec. 1, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including …

Original Article: FDA Approves Ogivri, the First Biosimilar for Treatment of Certain Breast and Stomach Cancers

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