A generic biologic in Canada?

November 12, 2019

By Ghislain Gauthier

Forteo (teriparatide, Lilly) is a biologic manufactured using recombinant DNA technology. Teva, using Forteo as the Canadian Reference Product (CRP), submitted a version of teriparatide produced using solid phase chemical synthesis which means it is a pharmaceutical and not a biologic. The product was found to meet the regulatory definition for pharmaceutical equivalence because it contains the identical medicinal ingredient in the identical quantity as the CRP, is administered via the same route and is sold in a comparable dosage form. As such, it was submitted and authorized via the ANDS pathway, meaning it’s a generic version of a biologic. This is not the first time Teva has submitted under an ANDS - they did the same for liraglutide using VICTOZA (Novo Nordisk) as reference.

At issue here is whether or not an amino acid sequence that can be manufactured outside of recombinant DNA is still a biologic, even if its CRP is. Expect this issue to persist particularly for peptides which are smaller and less complex than, for example, monoclonal antibodies (1,2).

For more information, please contact Ghislain Gauthier.

  1. https://www.smartbiggar.ca/insights/publication/court-strikes-novo-nordisk-s-judicial-review-application-of-minister-s-acceptance-of-teva-s-liraglutide-ands

  2. https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00548