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FDA Delays Action Date for Mylan and Biocon’s Herceptin Biosimilar

Sept. 11, 2017

The FDA pushed back its target review date three months for a trastuzumab biosimilar being developed by Mylan and Biocon.

The later date, Dec. 3, was needed to review clarifying information submitted during the application review process, a Biocon spokesperson said, adding the delay does not impact the company’s timetable for U.S. commercialization.

A biosimilar of trastuzumab, also known as Genentech’s Herceptin, has yet to be approved by the FDA. In 2016, Herceptin brought in $7 billion in international sales for Roche, Genentech’s parent company.

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