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Partnering for Phase III
RALEIGH, N.C.—Amgen and PRA, a leading clinical research organization (CRO), have recently announced a new development agreement for a series of Phase III studies to develop Amgen's biosimilar drugs on a worldwide basis. No financial details regarding the agreement were disclosed.
"This agreement reflects and confirms PRA's commitment to providing full-service support to our clients' development pipelines," Kent Thoelke, executive vice president of Scientific and Medical Affairs at PRA, said in a press release. "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."
Under the terms of the agreement, PRA will be the sole provider of CRO services for the Phase III studies. The Raleigh, N.C.-based CRO offers services in Phase I-IIa, bioanalytical laboratories, Phase II-III, late phase and minimal risk services, safety and risk management and therapeutic expertise. The agreement will cover the full scope of Amgen's global biosimilar portfolio, and will focus specifically on the development of the portfolio.
Mary Klem, director of corporate communications at Amgen, says PRA will serve as a full-service provider for Phase III clinical trials, handling day-to-day activities related to planning and conducting the necessary clinical trials for securing approval for biosimilar medicines. While she notes that "Amgen expects that PRA will be the only CRO providing Phase III clinical trial services for the program," she adds that the company "is not obligated to use only PRA for these services."
PRA did not respond to requests for further comments regarding the agreement.
"PRA has a strong track record in executing its clients' global registration trials and helping to bring new drugs to market positions," says Klem. "This CRO has expertise across all phases of the development process and offers services in 80-plus countries. The company demonstrated a solid understanding of the emerging biosimilar landscape and exhibited a strong desire to assist Amgen to compete successfully in this environment."
Biosimilars have been holding a place in the spotlight recently as the pharmaceutical industry seeks out the benefits of this class of drugs, resulting in recent collaborations and increased regulatory focus. Biosimilars, follow-on biologic drugs that are characteristically similar to existing drugs, offer a variety of advantages. Given that they share pharmacokinetic profiles and mechanisms of action with existing drugs, biosimilars do not require the same stringency of testing as the originals, allowing companies to enjoy fewer trials and to get their drugs to market sooner and less expensively.
Amgen considers biosimilars to represent "an exciting long-term growth opportunity," Klem notes, adding that the company feels it is "well positioned to provide safe and effective biosimilars to patients."
The agreement with PRA is Amgen's second biosimilar-focused partnership of late. Amgen announced a collaboration in December of last year with Watson Pharmaceuticals Inc. for the development and commercialization of several oncology antibody biosimilars on a worldwide basis. Amgen will assume responsibility for the development, manufacturing and initial commercialization of the oncology antibody drugs, and Watson will contribute up to $400 million in co-development costs, as well as development support, and will share product development risks with Amgen. The collaboration will not include biosimilars of Amgen's proprietary products, and products that result from the collaboration are expected to be sold under an Amgen/Watson label.