Interchangeable Biosimilar Product Development Workshop

FDA is announcing a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidance, research). The agency says the meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions on specific interchangeable topics, and a panel discussion with industry.

“Within 12 months following the public workshop, FDA will issue a draft strategy document for public comment that outlines the specific actions the agency will take to facilitate the development of interchangeable biosimilar biological products,” an agency notice says. “FDA will consider public input and will publish a final strategy document within nine months after the close of the public comment period on the draft strategy document.”