Reports: Amgen plans six biosimilars
NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.
Reuters reported that Amgen CEO Robert Bradway announced plans at a meeting with analysts and investors that the company would launch six biosimilars, including versions of Roche cancer drugs Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab), and Eli Lilly's cancer treatment Erbitux (cetuximab). It would also launch biosimilars of AbbVie's autoimmune disorder treatments Humira (adalimumab) and Remicade (infliximab).
The six drugs represent combined sales of more than $40 billion, Reuters quoted an analyst as saying.
The Patient Protection and Affordable Care Act mandated a regulatory approval pathway for biosimilars, though the Food and Drug Administration is still working on creating regulations to govern them. Currently, a company seeking approval for a follow-on version of an off-patent biotech drug must undergo the FDA's standard approval process for new drugs.