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FDA New Guidelines for Biosimilars and Biobetters: An Outlook for 2013

Toronto, Canada (PRWEB) January 14, 2013

The FDA plans to use a 'totality of the evidence' approach for approving Biosimilars. Evaluation of all available data submitted in support of the Biosimilarity of the proposed product, and the type or amount of analyses and testing required ensuring safety, purity, or potency will be determined on a product-specific basis.

The development of Biosimilars have garnered great interest for their cost-effective benefits in patient care as well as developmental opportunities for industry sponsors who see a new revenue stream. However, the pathway to commercialization is complicated by regulatory challenges. There is still a need to understand the expected requirements for biosimilar registration, as well as focused data requirements to establish a viable, safe and effective product.

The goal of this presentation is to provide an understanding of the current regulations and continued challenges, future directions by the regulatory authorities and provide insight to the regulatory pathway for biosimilar and biobetter registration.

A live Q&A with the audience will follow the main presentation. For more information, or to register for this event please go to

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