Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients.
Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights.
As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
Health Canada's decision to streamline biosimilar approval by removing routine Phase III efficacy trial requirements is fundamentally altering how innovators approach intellectual property portfolio management in the biologics space. The regulatory shift
Canada
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."
Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients.
Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights.
As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
