Herceptin biosimilar bandwagon gathers weight with new filing

1 August 2017

Following news last month that a US Food and Drug Administration (FDA) advisory panel had given its backing to a biosimilar version of Swiss pharma giant Roche’s (ROG: SIX) big-selling cancer drug Herceptin (trastuzumab), a separate copycat version has moved closer to market.

During its meeting in July, the agency’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to recommend approval of a Herceptin biosimilar developed Netherlands-incorporated Mylan (Nasdaq: MYL) and India’s Biocon (BSE: 532523).

Now Roche will note that US biotech Amgen (Nasdaq: AMGN) and Ireland-incorporated drugmaker Allergan (NYSE: AGN) have submitted a Biologics License Application (BLA) to the FDA for ABP 980, a biosimilar candidate referencing the same drug.

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