Biosimilars in the U.S. are far from the standard fare they're becoming in some countries, but the FDA expects them to be a steady portion of its workload.
Based on upcoming patent expirations of innovator biologics and the number of biosimilar applications it received in 2014, the agency reckons it will receive five biosimilar applications a year, according to an information collection notice scheduled for publication in Wednesday's Federal Register.
Even though it has yet to release guidance on what data are needed to demonstrate interchangeability, the FDA predicts it will receive two applications for interchangeable follow-on biologics a year. And that guidance? The agency is still expecting to get it out this year, it said in the notice.
While the numbers may not seem like much, a little context adds to their size. In 2013, the FDA received 12 applications for novel biologics. While seven new biologic applications