Further to our update in December 2017, here, below
is a mid-year update on biosimilar approvals, litigation and other news.
Approvals of biosimilars:
In the first half of 2018, Health Canada approved three biosimilars based on three different reference products, bringing the total number of biosimilar approvals to 12, based on 9 reference products*.
Manufacturer and date of approval
Review time (from filing to approval)
|HADLIMA, HADLIMA PUSHTOUCH||Samsung Bioepis, May 8, 2018||432 days||adalimumab|
|LAPELGA||Apotex, April 5, 2018||349 days||pegfilgrastim|
|MVASI||Amgen, April 30, 2018||487 days||bevacizumab|
Patent litigation involving biosimilars:
As previously reported, the Federal Court held a patent for Janssen’s REMICADE (infliximab) valid and infringed by Hospira’s biosimilar INFLECTRA.
Ongoing biosimilar litigation includes:
1. Filgrastim – after approval of Apotex’s GRASTOFIL, a biosimilar of Amgen’s NEUPOGEN, Apotex sued Amgen for section 8 damages, and Amgen separately sued Apotex for patent infringement. Amgen has also started an infringement action pursuant to the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) against Pfizer; the trial is scheduled to be heard January 2020.
2. Adalimumab – the litigation between AbbVie and Samsung Bioepis (applications under the PMNOC Regulations and an action for a declaration of non-infringement and impeachment) were discontinued shortly before issuance
of Samsung Bioepis’s notice of compliance (NOC) for HADLIMA, noted above.
3. Trastuzumab – Pfizer commenced five separate impeachment actions relating to five patents for trastuzumab, Hoffmann-La Roche (Roche)’s HERCEPTIN. Genentech and Roche’s infringement actions pursuant to the amended PMNOC Regulations are pending against Amgen (trial scheduled August 2019), Celltrion (trial scheduled September 2019) and Pfizer (trial scheduled November 2019).
4. Rituximab – Roche and Biogen’s four applications under the PMNOC Regulations, seeking prohibition orders relating to Celltrion’s rituximab product (a biosimilar of Roche’s RITUXAN), are scheduled for hearing in June 2019. Roche has also commenced four infringement actions pursuant to the amended PMNOC Regulations against Sandoz, which are scheduled to be heard January 2020.
5. Bevacizumab – Pfizer's action seeking a declaration of invalidity and non-infringement of a patent relating to Roche’s AVASTIN remains pending. Genentech and Roche discontinued their prohibition application under the PMNOC Regulations relating to Amgen’s proposed bevacizumab product shortly before Amgen's MVASI was approved.
6. Teriparatide - Relating to Eli Lilly's FORTEO, Eli Lilly has commenced an infringement action pursuant to the amended PMNOC Regulations against Apotex, which is scheduled to be heard January 2020.
In April 2018, Novo Nordisk applied to the Federal Court for various relief against the Minister of Health and Teva, broadly in relation to biologics and specifically in relation to Novo Nordisk’s biologic product VICTOZA (liraglutide). According to the pleading, Teva had filed an abbreviated new drug submission (ANDS) for its proposed Teva-liraglutide product based on a comparison to VICTOZA. The Minister certified Teva's ANDS. Novo Nordisk learned of the ANDS when it received Teva's notice of allegation, which was later withdrawn. The relief sought in the application includes a request for an Order restraining the Minister from granting an NOC for Teva-liraglutide based on VICTOZA as the Canadian reference product (CRP), an Order restraining the Minister from reviewing and approving any ANDS that relies on VICTOZA or any biologic product as a CRP, a declaration that a biologic cannot serve as a CRP, and, in the alternative, an Order directing the Minister to issue a policy or Guidance Document on the submission requirements for the use of a biologic drug as a CRP.
CADTH report on biosimilars
In January, the Canadian Agency for Drugs and Technologies in Health (CADTH) published an Environmental Scan: Biosimilars — RxIP - Regulatory, Health Technology Assessment, Reimbursement Trends, and Market Outlook. It reviews the RxIP - Regulatory frameworks, health technology assessment processes, and reimbursement trends for biosimilars in Canada and internationally, and describes the market outlook of biosimilars and their reference products in Canada.
Aligned reviews between Health Canada and health technology assessment organizations
On June 22, 2018, Health Canada issued a Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations (HTAs). As of the date of the Notice, sponsors may opt in for an aligned review by Health Canada, CADTH and l’Institut national d'excellence en santé et en services sociaux (INESS). All biological and pharmaceutical new drug submissions, including for biosimilars, are eligible, and sponsors may opt in at any stage in the review process by authorizing information sharing between Health Canada and the two HTAs. Starting in the fall of 2018, Health Canada will indicate which submissions on the “Submissions Under Review” lists are participating in an aligned review.
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.