Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in June 2022....more
On December 20, 2022, Ontario announced it is implementing a biosimilars transition policy. Starting March 31, 2023, patients receiving coverage from the Ontario Drug Benefit plan for the following innovator biologics can...more
On October 20, 2022, Saskatchewan announced it is introducing a biosimilars initiative. For any new patients starting a biologic drug, the Saskatchewan Drug Plan will only offer coverage for the listed biosimilar version....more
On December 1, 2021 the government of British Columbia announced that it is further expanding its biosimilar initiative. The statement reported that as of November 30, 2021 an estimated 30,000 patients on the rapid-acting...more
Mid-year update: Health products approved in 2021 – In October 2021, Health Canada published a “Mid-year update: Health products approved in 2021”, which provides an update on the drugs, medical devices, over-the-counter...more
Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more
On May 4, 2021, Amgen Canada announced the launch of their adalimumab biosimilar AMGEVITA (reference drug HUMIRA) for the treatment of 11 chronic inflammatory conditions. AMGEVITA is available as a prefilled syringe and a...more
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in August...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more
Update: On September 1, 2020, BRDD revised its Report to correct the “Biosimilars: Market Authorizations” tables....more
As part of the National Prescription Drug Utilization Information System (NPDUIS) initiative, the Patented Medicine Prices Review Board (PMPRB) has released three reports: 1) Market Intelligence Report: Combination...more
The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a report titled Utilization of Innovator Biologics and Biosimilars for Chronic Inflammatory Diseases in Canada: A Provincial Perspective. The...more
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more
Last week, Health Canada announced that biologic drugs, including biosimilars, will be identified “by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both the...more
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement...more
Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more
Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more
The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines (Notice of...more
As part of our series on current trends across different industries, we explore current changes taking place in the life sciences field. Privacy & Data Protection - Personal information protection and compliance...more