Pangaea Express: Amending the Food and Drug Regulations - Improving Access to Generics

The Feds are amending the Food and Drug Regulations to improve access to generics. The new Regulations will expand the criteria required to show generic equivalence to a Canadian reference product (CRP) thus allowing more generics to file an ANDS (abbreviated new drug submission). According to Health Canada, this is based on further experience and knowledge on what may be considered “identical.”

The Regulations will change what constitutes an identical medicinal ingredient to include different forms of the medicinal ingredient in comparison to the CRP but with the identical therapeutically active component. This is referred to as "in-situ changes" (e.g. when the medicinal ingredient undergoes a change in form during the manufacturing process of the dosage form). For example, generic drug products that have a different salt form from that of the CRP may yield the identical therapeutically active component as the reference drug and thus be eligible for filing through the ANDS pathway.

This could affect your LOE plans as another manufacturer that may have filed as an NDS (new drug submission) in the past may be able to file as an ANDS, be declared as equivalent and thus interchangeable according to payers. Health Canada estimates that four to five submissions per year would go through the ANDS pathway rather than the NDS pathway. A reminder that the current Generic Drugs Under Review List does not include company names. Health Canada sought stakeholder input on this matter and while feedback closed in February, there is no decision yet on whether the agency will adapt the same policies as for Submissions Under Review List.

With respect to biologics, Health Canada makes note that because Schedule D (i.e. biologic) drugs are made in living cells rather than through chemicals synthesis, a biosimilar can be shown to be highly similar to the reference biologic but not identical. As such the ANDS pathway is not appropriate. However, “the proposed amendments would not prevent a manufacturer from filing an ANDS for a drug that is not referred to in Schedule D (e.g. a chemically synthesized drug), where the CRP is a drug referred to in Schedule D.”

What it means is where a Canadian reference drug is a biologic, if it can be synthesized chemically (made outside a living system i.e. peptides), these could be submitted as an ANDS!

Interested persons may make representations concerning the proposed Regulations within 70 days after the date of publication of this notice. The proposed Regulations would come into force 90 days after being registered. The proposed amendments would not apply to drugs where the submissions for NDS, ANDS etc. were filed before the coming-into-force date.

For more information on how these Regulations may increase access to generics, please contact Ghislain Gauthier or Marla Weingarten.