Policy Change

An innovator company was notorious for requiring extensive trial information before supplying product for comparator purposes. The developer of the biosimilar was reluctant to submit trial details until 2 months after First Patient First Visit (FPFV) and posting on EUDRACT. In addition, lead times were going to be lengthened due to the need to relabel. BAP was able to

  1. point out the short comings in the innovators policy, which encouraged sourcing from the open market and gained acceptance to supply product in advance of receiving the trial information
  2. gained assurances from the biosimilar manufacturer that clinical trial information would be provided after supplies were received

With compromise from both parties, negotiated by BAP, supplies were able to be made. As a result of BAP high lighting short comings in the innovators approach to supporting biosimilar developments, namely the lack of transparency in supply and control over the product category, policy amendments were introduced.