After taking a stake in the emerging biosimilars market last December through a partnership with Watson Pharmaceuticals, Amgen has announced an exclusive agreement with clinical research organisation (CRO) PRA to conduct Phase III biosimilar trials.
The tie-up with Watson, under which Amgen assumed primary responsibility for product development, manufacturing and initial commercialisation while Watson is contributing up to $400 million in co-development costs and sharing product development risks, was for a number of antibody biosimilars in the oncology category.
Amgen’s agreement with PRA is for “a series of Phase III studies to develop several biosimilar drugs on a worldwide basis”, taking in “the entire anticipated scope of Amgen's global biosimilar portfolio”, the CRO noted.
The intention is that PRA will serve as the sole provider of CRO services for these trials, it added.
Last November PRA and another US-based CRO, Parexel International, entered into parallel strategic partnerships with Belgium’s UCB for operational clinical development worldwide.
The arrangement meant PRA and Parexel would “essentially become integrated members of our study teams”, UCB said at the time.