Mylan's Herceptin Advisory Committee May Be First Bumpy One For A Biosimilar

US FDA did not address production problems in its briefing document for upcoming Oncologic Drugs Advisory Committee meeting, but manufacturing deficiencies found at Biocon's facility could prompt questions.

Digital illustration of Cancer cell in colour background

Mylan NV's proposed biosimilar of Genentech Inc.'s Herceptin (trastuzumab), appears to have met all of FDA's requirements for approval, but the sponsor still may have to answer questions about its development partner's manufacturing issues.

FDA's overall conclusion was that the totality of evidence suggests that MYL-1401O is highly similar to US-approved Herceptin notwithstanding minor...

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