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Amgen signs biosimilar CRO deal with PRA

PRA will conduct a series of global phase III trials for the US biotech

Amgen has selected contract research organisation (CRO) PRA to help advance its late-stage biosimilar pipeline.

PRA will conduct phase III trials for several of the US biotech's biosimilars after the firms signed an exclusive global deal.

The strategic agreement “is intended to govern the entire anticipated scope of Amgen's global biosimilar portfolio,” PRA said.

Its executive vice president of scientific and medical affairs Kent Thoelke added: “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 programmes.”

Unlike traditional generics, the complexity of biologic manufacturing means that biosimilars are similar to their originator products, rather than an exact copy.

This complexity means that although prices will be lower than the biologics they're based on, biosimilars can still command a higher premium than traditional generic versions of small molecule drugs.

Amgen recently highlighted the importance of clinical trials in developing biosimilars in its response to the US Food and Drug Administration's (FDA) draft biosimilar guidance.

The company said: “Based on the limits of scientific knowledge today for human biology, Amgen believes that clinical studies will be necessary to demonstrate biosimilarity for the foreseeable future.”

It added: “The FDA's acknowledgement that determining interchangeability is scientifically difficult at this time is also important. Patient safety does not stop at approval and Amgen believes that distinguishable product names and post-approval activities, including ongoing monitoring, are essential.”

Late last year Amgen announced it would work with generics manufacturer Watson Pharmaceuticals to jointly develop and commercialise several cancer biosimilars.

Amgen will be primarily responsible for developing and manufacturing the versions of biological products, with Watson taking the lead role in their commercialisation and marketing.

2nd May 2012


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