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Smart & Biggar | 25 Nov 2020

Federal Court orders minister of health to issue NOC to Fresenius Kabi for biosimilar

Justice Manson of the Federal Court recently ordered the minister of health to issue a notice of compliance to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie's HUMIRA. The minister of health had completed its review of Fresenius Kabi's new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register......
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Smart & Biggar | Canada | 23 Nov 2020

Federal Court orders minister of health to issue NOC to Fresenius Kabi for biosimilar

Justice Manson of the Federal Court recently ordered the minister of health to issue a notice of compliance to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie's HUMIRA. The minister of health had completed its review of Fresenius Kabi's new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register......
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Smart & Biggar | 25 May 2020

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious

The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).
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Smart & Biggar | Canada | 20 May 2020

First decision under amended PMNOC Regulations: Federal Court finds Amgen's filgrastim patent obvious

The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).
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Smart & Biggar | 30 Mar 2020

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.
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Smart & Biggar | Canada | 25 Mar 2020

Federal Court of Appeal remands Remicade new use patent decision on anticipation and obviousness

In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.
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Smart & Biggar | Canada | 18 Mar 2020

New reports on utilisation of biologics and biosimilars for chronic inflammatory diseases

The Canadian Agency for Drugs and Technologies in Health and the Ontario Drug Policy Research Network (ODPRN) have released reports examining utilisation trends of innovator biologics and biosimilar versions of infliximab and etanercept, as well as the innovator biologic adalimumab, with regard to rheumatic conditions and inflammatory bowel disease in Ontario. This article examines the......
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Smart & Biggar | Canada, Mexico, USA | 15 Jan 2020

Amendments to USMCA remove 10-year data protection requirement for biologics

The United States, Mexico and Canada recently signed amendments to the US-Mexico-Canada Agreement (USMCA). The original USMCA was signed on 30 November 2018. The recent amendments have removed a provision, such that Canada can maintain its current data protection laws which provide an eight-year data protection term, with a possible six-month paediatric extension, for all pharmaceutical......
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Smart & Biggar | 25 Nov 2019

Update on biosimilars

Since June 2018 a number of biosimilar developments have taken place in Canada. For example, Amgen has sued BGP Pharma dba Mylan for patent infringement in respect of the pegfilgrastim biosimilar Fulphila, and Janssen succeeded in its patent infringement action against Hospira in respect of Hospira's biosimilar Inflectra.
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Smart & Biggar | Canada | 20 Nov 2019

Update on biosimilars

Since June 2018 a number of biosimilar developments – including with regard to approvals, pending submissions, regulatory matters, litigation and market access – have taken place in Canada. For example, Health Canada recently published an updated Biosimilar Biological Drugs in Canada: Fact Sheet, which provides an overview of the regulatory framework for biosimilar drugs in Canada.
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