Canada agrees to add to bio data exclusivity

Canada has signed a trade agreement with the US and Mexico that includes extending the data exclusivity period for biologics in Canada from eight to 10 years. Previously, off-patent industry associations representing all three territories had urged the rejection of such a provision – first mooted as part of an agreement in principle between the US and Mexico – as harmful to the biosimilars industry, claiming it would “benefit brand name drug companies to the detriment of public health and the affordability of medical care” (Generics bulletin, 7 September 2018, page 1).