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14 August 2019
The Federal Court recently struck Novo Nordisk's judicial review application challenging the minster of health's decision to accept for review an abbreviated new drug submission (ANDS) filed by Teva Canada for its Teva-liraglutide product, relying on Novo Nordisk's Victoza (a biologic) as a Canadian reference product.(1)
In striking the application, the court concluded that Novo Nordisk had neither direct nor public interest standing in the matter. In support of its argument for public interest standing, Novo Nordisk and the intervenor BIOTECanada argued that the minister of health had failed to apply the biosimilars guidance document to Teva's product, which requires that a submission for approval of a biosimilar must be made by way of a new drug submission, rather than by an ANDS, and must satisfy a more stringent standard than an ANDS.
However, the court found that it had not been established that Teva-liraglutide was a biologic, as it could have been chemically synthesised; therefore, it was speculative that the minister did not apply the biosimilars guidance document.
Further, the court held that it was also speculative that the minister had actually determined that Teva's submission was reviewable as an ANDS and capable of being approved by way of an ANDS, as the minister of health had accepted only the ANDS for review.
Novo Nordisk may appeal as of right. It has a pending action against Teva under the Patented Medicines (Notice of Compliance) Regulations relating to the same submission.
For further information on this topic please contact Urszula Wojtyra at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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