Mycophenolate Health Provider Information

Generic Mycophenolate Mofetil (Novo-Mycophenolate © )
to Replace CellCept © for Transplant Immunosuppression in BC
BC Transplant (BCT) is responsible for the cost of immunosuppressants required for transplant recipients in British Columbia.
Contracts for the procurement of drugs for BCT are negotiated through BC Health Shared Services (HSSBC), a
PHSA service designed to maximize efficiencies and cost savings across all health authorities in BC.
The patent for CellCept © 250 mg capsules and 500 mg tablets expired in November 2011. Since then seven mycophenolate
mofetil generics have been approved by Health Canada, and are now on the market. BCT’s goal is to provide
mycophenolate mofetil from one company and avoid switching among various generic companies. HSSBC has negotiated
a new contract for BC Transplant. The new mycophenolate mofetil contract for 250 mg capsules and 500 mg
tablets is now with the Teva Canada brand (Novo-Mycophenolate © ). BCT will continue to pay for CellCept © 200mg/mL
suspension (Roche).
Starting this month, BCT will begin the roll out process, and the Teva brand, Novo-Mycophenolate © 250 mg capsules
and 500 mg tablets will replace the Roche, CellCept © 250 mg capsules and 500 mg tablets. We will begin the process
of transitioning patients to Novo-Mycophenolate © starting July 16, 2012. We realize that a long lead-time plan
for implementation would be ideal, however, we have been advised by Roche that there will be a CellCept © 250 mg
capsule shortage beginning July 16th.
Beginning July 16, 2012, all new transplant recipients will be dispensed Novo-Mycophenolate © for their mycophenolate
mofetil prescriptions. As current patients come to clinic and require mycophenolate mofetil prescription renewals, they
will be dispensed Novo-Mycophenolate © . In addition, pharmacies will dispense Novo-Mycophenolate © to patients who
are refilling an existing prescription.
Why is BC Transplant making this change?
Novo-Mycophenolate © has met Health Canada’s standards for bioequivalence to CellCept © and is assumed to produce
the same therapeutic effect. Clinically important differences between generic and brand name drugs have not been
reported in well-controlled trials. The use of Novo-Mycophenolate © will create savings that can be redirected elsewhere
in the BC health care system. Roche has advised us there will be a shortage of CellCept © 250 mg capsules beginning
July 16, 2012.
What about patient safety?
While we do not expect any impact to patient safety, any patient side effects should be recorded and reported to the
patient’s attending physician and through pharmacy@bcts.hnet.bc.ca. This email will be monitored daily with clinical
follow up as required. Please use this email address if you have any questions or concerns regarding the roll out
process.
How will Novo-Mycophenolate © be prescribed?
When a prescription is written for mycophenolate mofetil, new transplant recipients will be started on the Teva brand,
Novo-Mycophenolate © . For patients already receiving mycophenolate mofetil, the clinic nurse and pharmacist will
advise the patient to use up their current CellCept © supply. Once the patient’s current CellCept © supply is finished the
patient will be dispensed Novo-Mycophenolate © .
What if a patient requests CellCept © ?
If a patient does not wish to take Novo-Mycophenolate © and requests CellCept © the patient will be required to pay the
difference in cost. BCT will only reimburse the BCT partner pharmacies the cost of Novo-Mycophenolate © .
Can patients be switched to Myfortic© to avoid Novo-Mycophenolate © ?
Myfortic © is not the same as CellCept © . Myfortic © , mycophenolate sodium is available in two different strengths,
180mg and 360 mg. CellCept© and Novo-Mycophenolate © contain mycophenolate mofetil and are available in 250 mg
and 500 mg strengths. BC Transplant only funds Myfortic © in cases where a patient has an intolerance to mycophenolate
mofetil.
transplant.bc.ca

What are the similarities between CellCept © and Novo-Mycophenolate © ?
Novo-Mycophenolate © and CellCept © have the identical active ingredient, mycophenolate mofetil. Novo- Mycophenolate
© has met Health Canada’s standards for bioequivalence as compared to the brand name drug CellCept © . Bioequivalent
drug formulations have the same bioavailability; that is the same rate and extent of absorption. As Novo-
Mycophenolate © is bioequivalent to CellCept © it is assumed Novo-Mycophenolate © will produce the same therapeutic
effect as CellCept © .
What are the differences between CellCept © and Novo-Mycophenolate © ?
Although the active ingredients are the same, the excipients (inactive ingredients) may differ between CellCept © and
Novo-Mycophenolate © . This is important in rare cases when a patient has an allergy or sensitivity to one of the excipients.
The biggest difference is cost. Novo-Mycophenolate © is less expensive than CellCept © . Novo-Mycophenolate © is
slightly different in colour, shape, and markings to CellCept ©
Novo-Mycophenolate © looks like this:
Novo-Mycophenolate ©
250 mg capsules
Novo-Mycophenolate ©
500 mg capsules
Novo-Mycophenolate © replaces the CellCept © (pictured below).
CellCept © 250 mg capsules
CellCept © 500 mg capsules
What about the variance in drug concentration?
There is a common misconception that generic drug concentrations can be 80% to 125% of the brand name formulation;
in other words, the variance may be up to 45%. This is not true.
One of the key parameters for bioequivalence is the area under the curve (AUC). The AUC is a mathematical calculation
based on a graph of blood concentration versus time, and it correlates well with total drug exposure. (see
attached graphs of the results of the bioequivalence studies performed by Teva © for 250 mg capsules and 500 mg tablets
compared to CellCept © 250 mg capsules and 500 mg tablets). The AUC of a generic formulation must be no less
than 80% or no more than 125% of the brand name formulation. There is international consensus that differences
less than this are not clinically significant.
More importantly, the 90% confidence interval of AUC must also fall within 80% to 125%. The confidence interval is a
range of measurements within which we can be confident the true result lies. Therefore as the entire confidence interval
is to fall within the 80% to 125% range, the variance is generally less than 5%.
References
1. Canadian Health Services Research Foundation [Internet]. Ottawa: CHSRF. Myth: generic drugs are lower quality and less safe than brand name drugs; 2007 Jun [cited 2012
July 3]. Available from: http://www.chsrf.ca/PublicationsAndResources/Mythbusters/ArticleView/07-06-01/0f090ed6-335a-463a-8cf0-55df449fc2c8.aspx
2. Kesselheim AS. The backlash against bioequivalence and the interchangeability of brand-name and generic drugs... CMAJ. 2011;183:1350-1352.
4. Canadian Agency for Drugs and Technologies in Health [Internet]. Ottawa: CADTH Similarities and differences between brand name and generic drugs;2012 [ cited 2012 May
1] Available from: http://www.cadth.ca/en/resources/generics/similarities
5. Canadian Agency for Drugs and Technologies in Health [Internet]. Ottawa: CADTH What are bioavailability and bioequivalence;2012 [ cited 2012 May 1] Available from: http://
www.cadth.ca/en/resources/generics
6. Rath T. Generic immunosuppressive drugs in kidney Transplantation. European Nephrology.2010;5:56-60.
The views and opinions expressed are those of the author and not necessarily those of any particular manufacturer.
transplant.bc.ca

BC Transplant was granted permission by Teva Canada July, 2012 to publish these graphs.