Health Canada issues draft generic biotech rule

Health Canada has issued a consultation document concerning the regulation of generic versions of biotechnology compounds in Canada,  classified as "subsequent entry biologics," with a cut-off date of May  26 for submissions. According to a Canada/USA-based law firm  specializing in intellectual property rights, Torys, "it is noteworthy  that SEB regulation will take place entirely through guidance  documents, not through any amendments to the Food and Drug Regulations  or to the Patented Medicines (Notice of Compliance) Regulations."

Eileen McMahon and Teresa Reguly, a partner and an associate with  Torys' Toronto unit, respectively, have co-authored a commentary about  the Health Canada draft guidance document. They note that SEBs will be  approved via the new drug submission pathway if the candidate is  demonstrated to have similarity with a reference product based on a  direct or indirect comparison.

The Canadian Generic Pharmaceutical Association, which last month issued  a call for a biogeneric review procedure to be introduced (Marketletter  March 9), said it "strongly supports the adoption of a separate approval  pathway." Among the benefits of an early adoption of regulations to  allow the marketing of post-patent versions of biotechnology agents,  the CGPA argues, is that "it would also expand the technological  capacity of Canada's world-class generic pharmaceutical industry and  lead to increased investments in highly-skilled jobs, manufacturing and  R&D."