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Drug Approvals Canada

Goodwin

Biogen Launches BYOOVIZ (ranibizumab) in Canada

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​​​​​​​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

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Lupin Announces Approval of ENBREL Biosimilar in Canada

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​​​​​​​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

Smart & Biggar

CADTH announces the launch of Post-Market Drug Evaluation Program

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On September 1, 2022, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced the launch of its Post-Market Drug Evaluation Program. Currently, CADTH’s Scientific Advice program offers pre-market advice...more

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Update on biosimilars in Canada – June 2022

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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

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International Biosimilar Approval and Launch Updates - February 2022

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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

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Update on biosimilars in Canada - October 2021

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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

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Proposed amendments to Food and Drug Regulations and Medical Devices Regulations would modernize the regulatory system for...

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On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more

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Health Canada Approves Celltrion’s Infliximab Biosimilar for Treatment of Rheumatoid Arthritis

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Celltrion Healthcare Canada Limited announced yesterday that Health Canada granted a notice of compliance for Remsima SC®, an infliximab biosimilar of J& J’s Remicade®, for the treatment of adult patients with rheumatoid...more

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First year of Project Orbis leads to 38 approvals of cancer therapies, including 8 by Health Canada

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Update: In the Mid-year update: Health products approved in 2021, Health Canada reported the approval of two additional cancer drugs in collaboration with Project Orbis partners between January and June 2021 – Retevmo...more

Foley Hoag LLP - Medicaid and the Law

CMS Weighs in on FDA Importation Rule

On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more

Smart & Biggar

Update on biosimilars in Canada – August 2020

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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 October...more

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Federal Court blocks Health Canada from disclosing veterinary drug submission records pursuant to ATI request

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Update: On September 24, 2021, the Federal Court of Appeal allowed the Minister’s appeal of this decision and remitted the matter to the Federal Court for redetermination of several issues: Canada (Health) v Elanco Canada...more

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Biosimilars: Comparison chart between Canada, US and Europe

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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

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PMPRB releases draft Guidelines operationalizing amended Patented Medicines Regulations

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On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more

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Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

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On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more

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Update on biosimilars in Canada – October 2019

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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 June 2018....more

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Health Canada updates Guidance Document: The Management of Drug Submissions and Applications

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On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of Drug Submissions and Applications....more

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FCA upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex omeprazole magnesium tablet ANDS

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On April 24, 2019, the Federal Court of Appeal (FCA) affirmed the Federal Court’s (FC) dismissal of Apotex’s application for judicial review of a decision by the Minister of Health relating to its Apo-Omeprazole (omeprazole...more

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Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

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Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more

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Health Canada and CADTH launch new initiative to provide early parallel scientific advice

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On February 28, 2019, Health Canada released a Notice to Industry announcing the Early Parallel Scientific Advice initiative. Currently, Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) offer...more

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Rx IP Update - January 2019

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IN THIS ISSUE: -Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative - PMPRB News: **PMPRB issues a Notice of Hearing for allegations of excessive...more

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Enjoy your cannabis hot chocolate, but not so fast on the cannabis beer

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The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more

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Certificate of Supplementary Protection Regime: First Anniversary Update

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September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more

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Rx IP Update - July 2018

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IN THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more

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Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

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