Pangaea Express: No more CADTH for Biosimilars

Biosimilars no longer need to be reviewed by CADTH.

"As of June 1, 2019, CADTH will be stopping work on any biosimilar reviews that would have been completed after June 1, 2019."

Manufacturers of biosimilars will still enter negotiations with pCPA as per the current process.

In rare circumstances (reference drug was not reviewed by CADTH), the biosimilar may require CADTH review.

We now have a simplified approval process with Health Canada, a pCPA process that favours biosimilars, and now, one more step to speed up the process, so jurisdictions have the ability to cover biosimilars, in favour of the reference biologic (at least for the drug naive patient), much more quickly.

"Is Canada moving towards the current process for generics which also do not undergo CADTH review?

For more information, please contact Marla Weingarten.