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
Biosimilars 2018 - A Year in Review
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more
Manitoba has implemented a Biosimilars Initiative effective August 1, 2024. Manitoba is the last province in Canada to implement a biosimilar policy that requires patients receiving funding under the Manitoba Pharmacare...more
On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection. The changes are described as being made to reflect current administrative practices, and to...more
On April 15, 2023, Health Canada proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (together, the “Proposed Amendments”). The Proposed Amendments are intended to modernize the frameworks...more
The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a consultation document for a Proposed Process for Time-limited Reimbursement Recommendations. The time-limited reimbursement recommendations would...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 March 1, 2023, Biogen Canada Inc. announced that BYOOVIZTM (ranibizumab injection), a biosimilar to Genentech’s LUCENTIS, is now available in Canada. BYOOVIZ is an anti-VEGF (vascular endothelial growth factor)...more
This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial...more
On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). HADLIMA is indicated for the treatment of...more
Organon, a global woman’s health company, recently announced its launch of two biosimilar products in Canada. On November 7, Organon announced the launch and availability of AYBINTIO in Canada....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 September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada. Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic,...more
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 October 2021....more
On May 19, 2022, Viatris Inc. and Biocon Biologics Ltd. announced that ABEVMY, a bevacizumab biosimilar, is now available in Canada. According to the press release, Viatris and Biocon Biologics co-developed ABEVMY, which...more
On March 22, British Columbia’s Ministry of Health announced that three new enoxaparin biosimilars, Valero Pharmaceuticals’ REDESCA, Juno Pharmaceuticals’ NOROMBY, and Sandoz’s INCLUNOX, would be covered by PharmaCare, the...more
Samsung Bioepis Co. Ltd. announced that Health Canada approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer, Metastatic Breast Cancer...more
On February 4, 2022, Nova Scotia announced that as part of the Nova Scotia biosimilar initiative, Nova Scotians enrolled in Pharmacare programs will have 12 months (until February 3, 2023) to work with their healthcare...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
According to various reports, Celltrion has received approval from Health Canada for YUFLYMA, a biosimilar of AbbVie’s HUMIRA product. YUFLYMA was previously approved in Europe, and is a high-concentration, low-volume,...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 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs. The announcement stated that similar to other...more
On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar. The drug is a trastuzumab emtansine biosimilar - using Genentech’s Kadcyla as the reference product - that will be marketed...more
Further to our post last week on British Columbia’s policy requiring “switching” patients taking Humira, the Alberta government has also implemented a policy, effective May 1, 2021, of requiring that patients over the age of...more