Canada upholds decision to approve biosimilars where reference product is not marketed

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Canada upholds decision to approve biosimilars where reference product is not marketed

INICIO/Políticas y legislación | Posted 30/09/2022 0 Post your comment

In court proceedings that concluded in August 2022, the Canadian Federal Court dismissed applications for judicial review put forward by AbbVie regarding the approval and marketing authorization of JAMP Pharma's Simlandi (adalimumab) product [1]. This confirms that Notice of Compliance (NOC) regulations do not apply to biosimilars when reference products are not marketed in Canada.

The judicial review was put forward by AbbVie following the marketing approval of JAMP’s Simlandi product, a biosimilar of AbbVie’s Humira. AbbVie holds NOCs for Humira in several concentrations. However, it only sells the 50 mg/mL and 100 mg/mL presentations in Canada. Despite this, several patents are listed in respect of the various presentations of Humira on the Canadian Patent Register.

JAMP filed a new drug submission (NDS) for its biosimilar adalimumab product in three presentations that are not marketed by AbbVie in Canada: (i) a 40 mg/0.4 mL pre-filled syringe; (ii) a 40 mg/0.4 mL auto-injector pen; and (iii) an 80 mg/0.8 mL pre-filled syringe). Upon submission of the NDS, JAMP went forward with the view that it was not required to address any of the patents listed on the Patent Register for Humira, as its presentations corresponded to non-marketed presentations of the originator. Health Canada ruled that the 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject to the 24-month statutory stay pursuant to the Patented Medicines (Notice of Compliance) Regulations because AbbVie Corporation, the marketer of Humira, elected to not market the equivalent high-concentration versions to Canadian patients [1].

As part of this move to approve these presentations of Simlandi, the Minister for Health made two decisions. Firstly, the Minister found that JAMP is not a ‘second person’ under subsection 5(1) of the Regulations and that the drug referred to in s. 5(1) must be drug identification number (DIN) specific and limited to the same presentations as the reference biological drugs, which at the time of NDS filing, were not marketed by AbbVie in Canada. As such, JAMP was not required to address the patents listed on the Patent Register in respect of Humira in pursuing its Simlandi submission.

Secondly, the Minister issued NOCs to JAMP for its three presentations of the Simlandi biosimilar.

The court denied AbbVie’s request for judicial review and held that the Minister's decision interpreting the NOC Regulations as applying only to a single version of a drug with a DIN that is marketed in Canada was reasonable.

This could be seen as a way to circumvent originator patents when not all presentations are marketed in Canada. Originator companies are warned that in not marketing their approved products, biosimilar versions may be approved and launched in their stead.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Canada approves adalimumab biosimilars Simlandi and Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 30]. Available from: www.gabionline.net/biosimilars/news/Canada-approves-adalimumab-biosimilars-Simlandi-and-Yuflyma

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