Follow–up from Health Canada regarding Generic Forms of Concerta

CADDAC National Director

This past week, a follow-up letter was received from Marion Law, the Director General of Health Canada’s Therapeutic Products Directorate (TPD) addressing discussions during the Oct 31 meeting with Janssen, CADDAC  and ADHD medical experts.

The letter noted that:

  • During the meeting with Health Canada, concerns were expressed by patient and physician organizations about the equivalence of generic versions of Concerta
  • TPD has been actively monitoring the issues that were expressed regarding bioequivalence requirements for generics to Concerta. TPD is aware of recent action by counterparts in the United States (FDA) and the European Union including publishing up-dates on the guidance on requirements for evaluating multiphasic modified release products (time released medications) for bioequivalancy
  • In follow-up to our meeting, TPD met with colleagues in the Marketed Health Products Directorate (MHPD). This Directorate is currently conducting an assessment of  Canadian Adverse Event Reports where a generic product substitution for Concerta might result in issues with clinical effectiveness
  • TPD is also considering approaches described in recently published international guidelines on determining bioeqivalence of multiphasic modified release products (time released medications)
  • Should changes be required in the Health Canada guidelines, stakeholder consultation will be included with possible additional targeted stakeholder feedback
  • Results of this Health Canada assessment possibly in conjunction with results expected in late 2017 from a study commissioned by the FDA, will inform next steps taken by Health Canada (TPD)
  • As TPD works through this process Stakeholders will be advised on key developments

CADDAC will continue to communicate with Health Canada, monitor the situation and report back to our stakeholders.


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