IN THIS ISSUE:
Apotex granted damages from contract research organization for delayed FDA approval of two products
Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed
Health Canada News
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New guidance document on administrative processing of submissions and applications
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Consultation on the Use of a Foreign-sourced Reference Product as a Canadian Reference Product
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Health Canada implements mandatory use of the Electronic Common Technical Document format
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Stakeholder consultation on naming of biologic drugs, including biosimilars
New court proceedings
Apotex granted damages from contract research organization for delayed FDA approval of two products
by Abigail Smith
On December 22, 2017, Patillo J. of the Ontario Super Court of Justice held that Apotex was entitled to $11,303,131.80, plus pre-judgment interest, for losses flowing from delays in the US Food and Drug Administration (FDA)’s approval of Apotex’s amoxicillin-clavulanic acid and levodopa-carbidopa products caused by the contractual breaches and negligence by MDS Pharma Services (MDS): Apotex Inc v Nordion (Canada) Inc, 2017 ONSC 1323. Apotex contracted with MDS, a full-service pharmaceutical contract research organization, to carry out bioequivalence studies that were included in Apotex’s US regulatory submissions for the aforementioned products. Due to MDS’s failure to comply with the US regulatory framework for conducting such studies, Apotex was unable to rely on the MDS studies, which required Apotex to repeat the studies, delaying US market entry.
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Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed
By Kevin Siu
We previously reported that the Federal Court dismissed a Patented Medicines (Notice of Compliance) (PMNOC) Regulations application relating to Apotex's generic aripiprazole product (BMS and Otsuka's ABILIFY) on a summary basis under s. 6(5)(b) of the PMNOC Regulations. An appeal was subsequently filed. On December 15, 2017, the Federal Court of Appeal granted a motion by the appellants BMS and Otsuka to stay the dismissal order until the appeal could be heard: Bristol-Myers Squibb and Otsuka Pharmaceutical v Apotex, A-386-17. The appeal was allowed on January 25, 2018 on consent of the parties.
Health Canada News
New guidance document on administrative processing of submissions and applications
By Brandon R. Heard
On December 11, 2017, Health Canada announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway. The administrative pathway will be available, with some restrictions, in circumstances including: a manufacturer or product name change, additional product names, or licensing agreements between two manufacturers. “Any deviations from the previously approved product will not be acceptable under the administrative pathway.” This Guidance replaces the “Changes in Manufacturer’s Name and/or Product Name Policy” and is effective March 1, 2018. For application of the PMNOC Regulations, the Guidance refers to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
Consultation on the Use of a Foreign-sourced Reference Product as a Canadian Reference Product
By Andrew Mandlesohn
On December 18, 2017, Health Canada published a Notice soliciting comments and recommendations from stakeholders regarding potential changes to its Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product. The Guidance, which took effect November 24, 2017 (previously reported), is directed to sponsors of all Abbreviated New Drug Submissions or Abbreviated Extraordinary Use New Drug Submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed in a country other than Canada (i.e., under the Canadian Reference Product definition provided in paragraph (c) of section C.08.001.1 of the Food and Drug Regulations). Stakeholder feedback, preferably in electronic form, should be submitted to Health Canada by March 18, 2018.
Health Canada implements mandatory use of the Electronic Common Technical Document format
By Katie Lee
As previously reported, Health Canada announced January 1, 2018 as the proposed date for mandatory filing of specified regulatory activity. On January 12, 2018, Health Canada published the Updated: Notice - Mandatory use of the Electronic Common Technical Document (eCTD) format serving as confirmation of that date. All new drug submission (NDS), supplementary new drug submission (SNDS), abbreviated new drug submission (ANDS) and supplemental abbreviated new drug submission (SANDS) regulatory activities for human drugs, as well as additional information and subsequent regulatory activities/transactions, must be filed in eCTD format as of January 1, 2018. Exemption requests must be submitted, and will be considered on a case-by-case basis.
Stakeholder consultation on naming of biologic drugs, including biosimilars
By Urszula Wojtyra
On January 18, 2018, Health Canada and the Institute for Safe Medication Practices Canada (ISMP Canada) opened its consultation on different approaches to the naming of biologic drugs, including biosimilars (see our Update on Biosimilars). The objective of the consultation is to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication-use process, including prescribing, dispensing, and adverse drug reaction reporting. Stakeholder views on the aforementioned topics will inform Health Canada's ultimate policy decision on the naming convention for biologic drugs.
New Court Proceedings
For complete details about these pharmaceutical proceedings, click here.
trastuzumab (HERCEPTIN, HERZUMA): Genentech, Hoffmann-La Roche v Celltrion
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AstraZeneca v Apotex (NEXIUM)
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