Summary

Welcome to the eighth edition of Biosimilars Newsletter, a quarterly publication dedicated to keeping you updated on current biosimilars news, including the global regulatory landscape, biosimilars articles and reports, and company news as reported via company press releases. The “Hot Topic” for this issue looks at formal meetings between the FDA and sponsors, focusing particularly on meetings that occur during the development phase of a biosimilar biological product. Regulatory affairs experts, Isabella Atencio, Jo Hulbert, and Nancy Wilkens explore the benefits of these formal meetings, as well as outlining the five types of meetings that can occur between sponsors or applicants and FDA staff to discuss development of a biosimilar biological product and respective procedures for each meeting. You will also find information on the fee structure for the biosimilar Biological Product Development (BPD) program.

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Biosimilars Newsletter Volume 8, October 2015