bioRASI Comments At Public Hearing On FDA Draft Biosimilars Guidance

Leading Biosimilars CRO contributes to advancing solutions for follow-on biologics

bioRASI, a full service, global Contract Research Organization (CRO), announced recently that it has issued comments to the FDA in connection with the public hearing held last week on the Draft Guidelines Relating to the Development of Biosimilar Products.

"bioRASI is pleased that the FDA is making strides towards establishing a domestic approval pathway for these important drugs, which will provide patients with increased access to life saving medications," said Boris Reznik PhD, chairman of bioRASI. "Just as the Hatch-Waxman Act facilitated the approval and marketing of lower cost but equally safe and effective small molecule drugs, the pending regulations and accompanying legislation will allow for the delivery of follow-on biologics to a greater population in the US and abroad," Dr. Reznik continued.

"Many of our current clients are planning their expansion from generic drugs into the biosimilars market," asserted Dr. Reznik. "As a powerful leader in generic drug development, bioRASI is leveraging our ten years of biologics experience to advance these clients on their path to success."

bioRASI has also commented on the three FDA issued guidance documents that were released on February 9th, 2012. Furthermore, bioRASI participated in the public hearing regarding these documents on May 11th, at which time bioRASI, together with biopharmaceutical opinion-leaders, was again given the opportunity to provide input on the draft guideliness. bioRASI's comments related primarily to facilitating the approval pathway for biosimilars in various conditions of use, and for the demonstration of interchangeability as a path that can potentially be beneficial both for patients and for the biosimilars industry as a whole.

About bioRASI
bioRASI is an award-winning Full Service Global CRO providing clinical development that optimizes its sponsors scientific, clinical, and business results. bioRASI facilitates obtaining drugs, biotherapeutics, and medical devices marketing approvals by delivering high quality regulatory and clinical strategies, solutions and services. The Company's unique access to the largest facilities and patient populations all over the world saves their clients critical time. bioRASI's services include program optimization, project management, regulatory, clinical, data management and analysis, compliance and audit. bioRASI is headquartered in Aventura, FL and has regional offices and operations across North America and around the world.

SOURCE: bioRASI