Double whammy for Roche as FDA advisory panel backs biosimilars of Herceptin and Avastin
At its meeting yesterday, the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously for recommending approval of biosimilars of two top-selling drugs from Swiss pharma giant Roche (ROG: SIX).
The ODAC recommended approval of proposed biosimilar of Herceptin (trastuzumab) from Netherlands-incorporated Mylan (Nasdaq: MYL) and India’s Biocon (BSE: 532523).
The committee voted 16-0 in support of eligible indications of the reference product, which include HER2-positive breast cancer in the metastatic and adjuvant settings. The branded product generated sales of $6.73 billion last year.
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