Urszula Wojtyra on biosimilars in Lexpert Special Edition: Health Sciences 2026
Principal Urszula Wojtyra was recently featured in the 2026 edition of Lexpert Special Edition: Health Sciences, offering perspectives on how regulatory change is reshaping intellectual property strategies in Canada's health sciences sector.
In "Biosimilars Gain Ground as Health Canada Streamlines Approval Process", she explores the scientific and commercial implications of Health Canada's decision to remove routine Phase III efficacy trial requirements for many biosimilar submissions. In the article, she emphasizes the magnitude of the difference between traditional small-molecule pharmaceuticals and biologics.
"Previously, biosimilar manufacturers had to register phase III clinical trials, which provided visibility into potential future competitors. Innovators will need to manage their IP portfolios more proactively."–Urszula Wojtyra, Principal
Read the full article in the Lexpert Special Edition: Health Sciences 2026.
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