FDA Committee Recommends Approval of Mylan Biosimilar to Herceptin

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies' proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin...

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Bibliographic Details
Published inPharmaceutical Processing
Main Author Mylan, N V
Format Trade Publication Article
LanguageEnglish
Published Rockaway Advantage Business Media 14.07.2017
Subjects
Biological products
Breast cancer
Committees
FDA approval
Malik, Rajiv
New Zealand
Canada
United States > US
Japan
Europe
Australia
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Summary:Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies' proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin (Roche/Genentech), which include HER2-positive breast cancer in the metastatic...
ISSN:1049-9156