The following provides an update on biosimilars in Canada.
Health Canada's guidance on biosimilars
In November 2016, Health Canada issued a Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (as previously reported). In March 2017, Health Canada held a Biosimilars Workshop and issued a report, which notes that Health Canada intends to consult with stakeholders about the impact of naming of biosimilars on prescribing, dispensing and pharmacovigilance needs.
Approvals and reviews of biosimilars to date
Health Canada approved two biosimilars in 2017 (noted in bold below), bringing the total number of biosimilars approved in Canada to eight, based on five reference products:
| Biosimilar | Manufacturer
and year of approval |
Review time
(from filing to approval or patent hold) |
Medicinal ingredient |
| OMNITROPE | Sandoz, 2009 | 748 days | somatropin |
| REMSIMA/INFLECTRA | Celltrion, Hospira 2014 | 427 days | infliximab |
| BASAGLAR | Eli Lilly, 2015 | 356 days | insulin glargine |
| GRASTOFIL | Apotex, 2015 | 1039 days[1] | filgrastim |
| BRENZYS | Samsung Bioepis, 2016 | 358 days | etanercept |
| ERELZI | Sandoz, April 2017 | 353 days | etanercept |
| RENFLEXIS | Samsung Bioepis, December 2017 |
N/A | infliximab |
Health Canada maintains a list (Drug and Health Product Submissions Under Review (SUR)) of all new drug submissions under review, including biosimilar applications.
Effect of CETA amendments to biologics
Unlike in the US, the patent litigation system and exclusivity for biologics in Canada is the same for biologics and small molecules. Thus, the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) apply to biologics. Notably for biologics, process claims for patents listed on the Patent Register can be asserted in actions under the PMNOC Regulations. Additionally, once a biosimilar manufacturer serves a notice of allegation, unlisted process patents can also be asserted outside the PMNOC Regulations. The existing data protection regime for novel compounds, including biologics – six years no filing plus two years no approval plus a possible six months pediatric exclusivity – remains unchanged. Finally, the new Certificates of Supplementary Protection apply to biologics.
Patent litigation involving biosimilars
Pending biosimilar litigation includes:
- Infliximab – the trial of an action for patent impeachment and infringement between Hospira/Celltrion and Janssen was heard in the fall of 2016 and January 2017. The decision is currently under reserve.
- Filgrastim – after approval of Apotex's GRASTOFIL biosimilar product of Amgen's NEUPOGEN, Apotex sued Amgen Canada for section 8 damages, and Amgen separately sued Apotex for patent infringement.
- Adalimumab – AbbVie's eight applications under the PMNOC Regulations, seeking prohibition orders relating to Samsung Bioepis's adalimumab, are scheduled to be heard in February 2019. Samsung Bioepis separately brought an action for a declaration of non-infringement and impeachment of Patent No. 2,872,089 relating to adalimumab, AbbVie's HUMIRA.
- Trastuzumab – Pfizer has commenced five separate impeachment actions relating to five patents for trastuzumab, Hoffmann-La Roche's HERCEPTIN. On December 11, 2017, Genentech and Hoffmann-La Roche commenced an infringement action pursuant to the amended PMNOC Regulations asserting four patents against Amgen Canada in respect of its proposed trastuzumab product. On December 18, 2017, three actions pursuant to the amended PMNOC Regulations were commenced against Celltrion in respect of its proposed trastuzumab product.*
- Rituximab* – Hoffmann-La Roche and Biogen's four applications under the PMNOC Regulations, seeking prohibition orders relating to Celltrion's rituximab product (Hoffmann-La Roche's RITUXAN), are scheduled for hearing in June 2019.
- Bevacizumab* – Pfizer has brought an action seeking a declaration of invalidity and non-infringement of a patent relating to Hoffmann-La Roche's AVASTIN. Genentech and Hoffmann-La Roche have brought a prohibition application under the PMNOC Regulations relating to Amgen's proposed bevacizumab product.
Pricing and reimbursement of biosimilars
The National Prescription Drug Utilization Information System, a research initiative that operates independently of the Patented Medicine Prices Review Board, issued a report in 2017 titled "Potential Savings from Biosimilars in Canada." According to the Report, Canada has a relatively high use of biologics, and the biosimilar prices are higher in Canada than in other OECD markets.
The Canadian Agency for Drugs and Technologies in Health (CADTH) has proposed revisions to streamline the submission and review process for biosimilars through the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR) programs and is currently reviewing comments.
Footnotes
[1] Calculated based on the patent hold date (May 21, 2015) in Apotex's statement of claim in Court File No. T-934-16.
[*] Updated after initial publication.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
