Keeping an Eye on The Ultimate Goal – How to Ensure Success In Developing Complex Generics

One of the popular sessions in GRx+Biosims Conference held in Bethesda on November 4, 2019 was about Developing Complex Generic Products – How to Ensure Success. The session involved presentation and discussion by FDA and industry. Both sides agreed that the most important factor in assuring success in the development of complex generic is communication, during both development and review.

The industry presented the importance of understanding the goals of the granted meetings with FDA. “Without a clear purpose, a precious FDA meeting may not yield desired results”, Gregg DeRosa of Teva stressed. The FDA representative, Robert Lionberger, agreed.

FDA also stated that when a product specific guidance (PSG) is available, the path of least resistance to development of a complex generic may be to follow it. However, if the sponsor wishes to propose an alternative study approach, they need to decide if they would rather request an FDA meeting or try their luck with a controlled correspondence.

FDA indicated that there aren’t enough pre-ANDA meeting requests compared to  product development related meeting requests. This could be due to time constraints experienced by the generic companies during the product development. However, Lionberger commented that these meetings may serve dual purposes: to provide valuable insight to the sponsor to provide support and a smooth review of their ANDA; and could also prepare the FDA reviewers for the upcoming submission.

Based on the frequent revisions to the PSGs , the audience suggested that the FDA consider publishing a PSG in track changes form, when it is updated or have a repository of old PSGs. FDA stated that it was not being considered by them at this time.  It is a bit odd that FDA demands that firms that make revisions to their standard operating procedures (SOPs) must have a revision history explaining what changes were made, yet does not do so for its product specific guidances that industry is suggested to follow.

Overall, it was an interesting session and it appeared from the presentations and the discussion that timeliness and sharp focus on purpose is prime in ensuring success in meetings with FDA related to complex generics.