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Biosimilars.
Comparison between Canada, US and Europe.
As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and Camilla Balleny of Carpmaels & Ransford to prepare the chart below comparing relevant considerations for biosimilars in Canada, the US, and Europe, including regulatory pathways, data protection and patent linkage.
Canada
Regulatory approval pathway for biosimilar
Same formal pathway under Food and Drug Regulations as for innovator biologic drugs, but see: Guidance, e.g. must establish similarity to reference product.
Reference product
Innovator biologic approved by Health Canada; use of nonCanadian sourced version as a proxy in comparative studies may be permitted.
US
Distinct pathway - "Biologics Price Competition and Innovation Act (BPCIA)"
Must establish "biosimilarity" and/or "interchangeability" to reference product.
Innovator biologic approved by FDA. Use of non-U.S. sourced version as proxy may be permitted provided there are comparative bridging studies.
EU
Biosimilars of medicinal products authorised via the Centralised Procedure will have automatic access to the Centralised Procedure. Comparability studies with the reference biologic will test quality, safety and efficacy.
Innovator biologic authorised in the European Economic Area (EEA). Use of a non-EEA authorised version of the reference product may be possible but this needs to be authorised by a regulatory authority with similar scientific and regulatory standards as EMA.
Extrapolation of indications possible for biosimilar?
Yes
Yes
Yes
Created: November 2019 This information sheet is intended to provide general information only on the indicated topic. For specific advice please contact a member of our firm or any of our offices. Smart & Biggar services are provided by the law firm Smart & Biggar LLP and the patent and trademark agency Smart & Biggar IP Agency Co. For more information on our structure visit smartbiggar.ca/legal
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Interchangeability
Biosimilar average approval time Transparency of biosimilar filings
Biosimilar naming
Patented medicine price regulation
Canada
No declaration of equivalence by Health Canada (unlike for most generic drugs). Designation of a drug as interchangeable is in purview of provinces/territories.
US
FDA can designate biosimilar as "interchangeable" (additional proof required). See FDA Guidance on Interchangeability (May 2019).
EU
These decisions are outside the remit of the EMA; individual member states' national competent authorities will make these decisions. Individual states will have access to the scientific evaluation performed by the Committee for Medicinal Products for Human Use (CHMP).
2018/2019, approval of biologics, including biosimilars: average of 12.5 months, median of 11.5 months.
Submissions under review includes sponsor name, INN and submission class of `biosimilar'.
All biosimilars share same INN as the reference product plus a unique brand name. Both unique brand name + INN should be used throughout medication use, see: Policy.
Both innovator and biosimilar are subject to jurisdiction of Patented Medicine Prices Review Board if a "patentee".
Average time is 15.5 months.
Until approval, no information is available.
New draft guidance (March 2019). Different standards for biosimilars and interchangeable biosimilars. With some exceptions, biologic reference products and biosimilars have a four lowercase letter suffix added to the INN. No
Approximately 12 months from application at the EMA.
Monthly list of medicines under evaluation for biosimilars this only includes the INN, the therapeutic area and the total number of applications for that biosimilar in each given month. All biosimilars share same INN as the reference product plus a unique proprietary name.
No
Created: November 2019 This information sheet is intended to provide general information only on the indicated topic. For specific advice please contact a member of our firm or any of our offices. Smart & Biggar services are provided by the law firm Smart & Biggar LLP and the patent and trademark agency Smart & Biggar IP Agency Co. For more information on our structure visit smartbiggar.ca/legal
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Data protection for innovator biologic
Canada
Six years of data exclusivity, parallel eight years of marketing exclusivity (8.5 years with pediatric extension); will extend to at least 10 years under the USMCA amendments.
US
12 years of data exclusivity (plus 6 months pediatric exclusivity).
EU
Eight years of data exclusivity, parallel ten year period of marketing exclusivity. The latter may be extended to max. 11 years if, during the first eight years of the marketing authorization (MA), the MA holder obtains an authorisation for one or more new indications (+ 1 year).
Pediatric exclusivity for innovator biologic
Orphan drug exclusivity for innovator biologic
Additional 6 months of marketing exclusivity under data protection only.
None.
Adds 6 months to all exclusivities.
6 months extension of Supplementary Protection Certificate (SPC) where a paediatric investigation plan (PIP) is carried out and results are included in the product information OR additional two years of market exclusivity for completion of the PIP where the innovator product is an orphan medicinal product (see below).
Possible. Seven year orphan drug exclusivity does not extend 12-year data exclusivity.
Possible. Parallel to data protection above, a ten year period of market exclusivity for orphan medicines, during which time the EMA and member states may not accept another MA application for the same therapeutic indication in respect of a similar medicinal product.
Created: November 2019 This information sheet is intended to provide general information only on the indicated topic. For specific advice please contact a member of our firm or any of our offices. Smart & Biggar services are provided by the law firm Smart & Biggar LLP and the patent and trademark agency Smart & Biggar IP Agency Co. For more information on our structure visit smartbiggar.ca/legal
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Patent linkage
Supplementary protection for innovator biologic
Number of biosimilar approvals/reference products
Canada
Same as for generic drugs: PMNOC Regulations, like Hatch-Waxman Act litigation (see comparison chart here). Patents listed on Patent Register.
Certificate of supplementary protection (CSP) for up to two years may be available.
Patent term adjustment due to Patent Office delays will be available under USMCA amendments.
18 biosimilars approved of 11 innovator reference products (Health Canada does not maintain a list, but see table here).
US BPCIA controls patent litigation procedure. No resemblance to Hatch-Waxman procedure.
Patent term extension (PTE) of up to two years past the expiration of the 12-year data exclusivity. Also, patent term adjustment (PTA) available to patents due to Patent and Trademark Office delay.
25 biosimilars approved of 9 innovator reference products (list here).
EU None.
A Supplementary Protection Certificate (SPC) may be available to increase patent term up to a maximum of five years. An additional 6 months may be available for those products which have been submitted according to a PIP.
53 biosimilars approved of 18 innovator reference products (list here)1.
1 Currently 53 approved for use in Europe, 2 refused, 8 withdrawn
Created: November 2019 This information sheet is intended to provide general information only on the indicated topic. For specific advice please contact a member of our firm or any of our offices. Smart & Biggar services are provided by the law firm Smart & Biggar LLP and the patent and trademark agency Smart & Biggar IP Agency Co. For more information on our structure visit smartbiggar.ca/legal
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