Home » FDA Delays Action Date for Mylan and Biocon’s Herceptin Biosimilar
FDA Delays Action Date for Mylan and Biocon’s Herceptin Biosimilar
September 8, 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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