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The 2017 PDA Biosimilars Conference will bring together industry experts and regulators to discuss the latest advancements and strategies required to successfully bring biosimilars to market. In response to the industry’s need for current and reliable information on this rapidly growing area of pharmaceutical manufacturing, PDA will convene industry experts and regulators to review successful development strategies for biosimilars.

Multiple speakers from various health authorities will provide their experience and views on key aspects for a biosimilar development program, setting the framework for what should be included in a marketing application. Other conference sessions will address Demonstration of Analytical Similarity, Post-Marketing Change Management, Control Strategy for Biosimilars, Product Specifications for Biosimilars and “Data Quality” Expectations for Biosimilars.

Throughout the Conference, successful case studies and practical examples will be used to illustrate how analytical similarity can be demonstrated and practical control strategies be developed. Current updates from the regulatory agencies, including the U.S. FDA, EMA and Health Canada, will be presented, and CMC reviewer perspectives will elucidate those CMC issues that have been most challenging to approve. Attendees will have the opportunity to raise questions and concerns during the conference.

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