Generic Concerta was introduced into Canada around February 2010. As I’ve written in my full article about Generic Concerta – I’m quite concerned about the fact that the new generic medicine does not have the same properties as brand name Concerta – and this may lead to problems for patients who are automatically switched from brand name Concerta to Novo-Methylphenidate ER C.
You may wonder – am I against generic medicines?
Not at all.
In fact, I have taken many generic medicines myself, and so have my family members.
The issue is that for most people, taking a generic for stomach issue, or for asthma is often completely fine. It is however different, in my opinion, to take a generic for a psychiatric condition, such as ADHD.
The other big difference is that Concerta was developed based on the principle that its pharmacokinetic profile is different. What does that mean? It means that the way the medicine is absorbed throughout the day has an impact on how the medicine works.
In other words – in this ‘next generation’ medicine – the old rules for how to create a generic shouldn’t really apply. Just assessing whether the new generic has similar medicine absorbed throughout the day misses the fact that the rate of absorption of Concerta is part of what makes it so effective.
Thankfully, our friends at Health Canada are listening. They have at least acknowledged that there may be a difference with how they should evaluate generics when it comes to medicines like Concerta.
Health Canada has created a committee called: The Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF). Their draft terms include the following wording:
“The Scientific Advisory Panel (SAP) on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF) provides advice to Health Canada on appropriate bioequivalence standards for modified-release dosage forms of pharmaceutical drugs. Of particular interest are those drugs where concerns have been raised that existing standards may not be adequate, for example, methylphenidate and nifedipine. The Panel provides Health Canada with advice and recommendations, but the decision-making responsibility remains with Health Canada.”
This committee will be meeting in Ottawa on June 11, 2010 to receive input and submissions to understand the complexity of this issue.
Hopefully, this process will bring forward the science that Novo-Methylphenidate ER-C does NOT have the science behind it to be defined as a generic form of Concerta. This would then change it to be another lower cost option for people to use for ADHD, rather than a medicine which is automatically substituted for Concerta.
I will update this blog with information as I receive it.