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PRA announces a new agreement with Amgen for a series of Phase III studies to develop several biosimilar drugs on a worldwide basis. It is intended that PRA will serve as the sole provider of CRO services for these studies. A global leader in the biotechnology space, Amgen conducted a thorough search process to identify a CRO for Amgen’s biosimilar development program and selected PRA. Amgen and PRA signed the agreement in April 2012.
Under the new agreement, Amgen and PRA will work together to execute Phase III studies related to Amgen’s current biosimilar portfolio. The agreement is intended to govern the entire anticipated scope of Amgen's global biosimilar portfolio.
“This agreement reflects and confirms PRA’s commitment to providing full service support to our clients’ development pipelines,” said Kent Thoelke, PRA’s Executive Vice President of Scientific and Medical Affairs. “Our mission is to assist our clients across all phases of biotech drug development by combining therapeutic and operational expertise with local knowledge to help them meet their development goals. As such, this relationship represents a key milestone in PRA's commitment to supporting our clients’ biosimilar development programs. Amgen is a blue chip company and a world leader with a global reputation for excellence in bringing biologic therapies to patients with grievous illnesses. PRA has a strong track record in executing our clients’ global registration trials and helping to bring new drugs to market. We are delighted to announce this strategic relationship with Amgen.”