Canada

Partners Fresenius and Formycon have racked up another pair of approvals for their Otulfi ustekinumab biosimilar rival to Stelara, this time in the UK and Canada.

As efforts to improve diversity in clinical trials gain momentum globally, regulators in the UK, the EU, Canada, Australia and Japan were asked about their efforts to support representative enrolment. 

We review the most notable regulatory developments of the past year, with experts outlining for Generics Bulletin the regulatory to-do list for 2025.

This year, regulators questioned the US interchangeability designation and the need for comparative efficacy trials, while finding ways to promote biosimilar development and accessibility. Will this momentum continue in 2025? Generics Bulletin spoke to experts from across the industry to hear their views.

After a year of multiple regulatory milestones for its Omlyclo, Celltrion celebrates the first omalizumab biosimilar approval in Canada.

A new methods guide from Canada’s health technology assessment agency should help drug sponsors generate and report appropriate clinical evidence.

A new, international group of health technology assessment agencies will work together on topics related to health economic methods that could include dynamic pricing and non-traditional ways of evaluating value in cost-effectiveness analyses.

As mandated by the recent Pharmacare Act in Canada, a new committee will make recommendations on how Canada can provide universal drug coverage to it citizens.

Canada’s shortage of children’s analgesic/antipyretic OTCs in 2022 as COVID-19 and seasonal flu virus combined to drive stockpiling by consumers. Some poison control centers and hospitals offered recommendations about modifying adult doses to pediatric use.

The latest campaign from Biosimilars Canada, #SaveBigWithBiosimilars, targets businesses to raise awareness of the benefits of using biosimilars for employee health benefit plans.