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American Conference Institutes Summit on U.S. BIOSIMILAR Essential Training in Europe on the Legal, Regulatory, and Patent Realities of the U.S. Biosimilar Landscape April 21, 2015, Sheraton Munich

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What is us biosimilars - sughrue?

US biosimilars - Sughrue are biosimilar products that have been approved by the US Food and Drug Administration (FDA) as highly similar to an existing biological product, known as a reference product.

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Manufacturers of biosimilar products are required to file US biosimilars - Sughrue.

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To fill out US biosimilars - Sughrue, manufacturers must provide detailed information about the biosimilar product and its similarity to the reference product.

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The purpose of US biosimilars - Sughrue is to provide a pathway for the approval of biosimilar products that are highly similar to reference products and have no clinically meaningful differences in terms of safety and effectiveness.

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Information that must be reported on US biosimilars - Sughrue includes data demonstrating the biosimilarity of the product to the reference product, as well as information on the manufacturing process, formulation, and container closure system.