Amgen enters biosimilars deal with PRA

Home/Pharma News | Posted 04/05/2012 post-comment0 Post your comment

Clinical Research Organisation (CRO) PRA announced on 26 April 2012 that it had entered into an agreement with US biotechnology giant Amgen as the sole provider of CRO services for ‘a series of phase III studies to develop several biosimilar drugs on a worldwide basis’.

picture 87

It seems that Amgen is hungry for deals at the moment, as the news comes just one day after Amgen announced it was to gain a majority share in Turkish generics company Mustafa Nevzat Pharmaceuticals (MN) [1].

PRA is a global CRO providing services through all phases of clinical development. PRA has supported over 3,100 clinical trials in more than 80 countries on six continents through their global offices, and is therefore well positioned to assist Amgen in carrying out its biosimilar trials.

According to PRA, Amgen conducted a thorough search process to identify a CRO for Amgen’s biosimilar development programme and selected PRA. Under the new agreement, Amgen and PRA will work together to carry out phase III trials for biosimilars. The agreement is intended to cover the whole of Amgen’s global biosimilar portfolio.

PRA’s Executive Vice President of Scientific and Medical Affairs, Mr Kent Thoelke, said that PRA were delighted to announce this strategic relationship with Amgen, adding that ‘this agreement reflects and confirms PRA’s commitment to providing full service support to our clients’ development pipelines. 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.’

The deal underpins Amgen’s commitment to biosimilars, following its landmark deal with Watson in December 2011 to develop and commercialise several cancer antibody biosimilars [2].

Related articles

New Amgen Enbrel patent could block biosimilars until 2028

2013’s biggest patent expiries


1.  GaBI Online - Generics and Biosimilars Initiative. Amgen buys Turkish generics manufacturer []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 May 4]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Amgen finally jumps on biosimilars bandwagon []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 May 4]. Available from:

Source: PRA

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010