FDA set to issue guidelines on biosimilars

(Ref: Chicago Tribune)
  • The FDA appears to be on the verge of issuing guidelines for the development of generic biologics, as reported in Chicago Tribune.
  • The FDA still plans to release the guidance by the end of the year but the agency's top drug official, Janet Woodcock, has indicated it could come "as early as the next few weeks, maybe even days," Janice Soreth, deputy director of the agency's Europe office in London said.
  • The U.S. agency has completed work on the guidance and expects to release it "promptly," Woodcock said, according to the biotechnology trade publisher BioCentury.
  • The agency has also reached a "tentative agreement" with industry representatives over user fees companies would pay to support the biosimilar approval process, according to minutes of a meeting posted on the FDA's website.
  • Soreth said an article written by FDA officials in last month's NEJM was an indicator of what the guidance might look like.
  • In the article, agency officials said in the article that approval for biosimilars "will require a new paradigm of sponsor-FDA interactions," involving analysis of much more data than traditional generic drugs.