The Canadian generics market faces a number of challenges, although provinces are now implementing strategies to increase competition in the market, and provide greater opportunities for smaller generics players. In terms of biosimilars, referred to as subsequent entry biologics (SEBs), Health Canada in March 2010 published its regulatory guidance for the approval of SEBs.

1. Canada: Generics and Biosimilars Overview
Published:November 2011
No.Of Pages:36
Price:US $ 1900
Introduction
The Canadian generics market faces a number of challenges, although provinces are now
implementing strategies to increase competition in the market, and provide greater
opportunities for smaller generics players. In terms of biosimilars, referred to as subsequent
entry biologics (SEBs), Health Canada in March 2010 published its regulatory guidance for
the approval of SEBs.
Features and benefits
* Compares the Canadian generics market in terms of value and volume to other leading
developed and emerging markets.
* Insight into the key drivers and resistors to generics uptake in Canada, and identifies key
small molecule brands set to face patent expiry.
* Assess the key requirements of the Canadian subsequent entry biologics (SEB) approval
pathway.
* Analyses biosimilar uptake in Canada and provides insight into the future opportunities for
biosimilar players.
Highlights
* The Canadian generics market is facing a number of challenges with strengthening
intellectual property laws threatening to delay market entry, while several provinces have
also introduced price cuts.
* Ontario banned pharmacist rebates in April 2010 in a move which should restore a greater
level of competition in the market, and provide greater opportunities for smaller generics
players. Furthermore, harmonization of provincial generic regulations would improve generic
uptake and reduce bureaucracy and confusion for generics companies.
* While the SEB market is in its infancy with Omnitrope (somatropin; Sandoz) the only
product currently available, it is expected that the introduction of the SEB approval pathway
will lead to further SEBs entering the market in the near future.
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Table Of Contents
EXECUTIVE SUMMARY
Introduction
Canada – Strategic scoping and focus
Canada – Datamonitor key findings
Generics market

2. Biosimilars market
Related reports
CANADA – GENERICS MARKET OVERVIEW
Canada – Generics market dynamics
Canada generics volume uptake
Canada generics value uptake
Canada generics market size
Canada – Generics drivers and resistors
Strengthening IP laws could cost Canada $2.8bn in lost savings
Generic exports to emerging markets set to increase
Pharmacist rebate agreements lead to high generics prices and exclude all but the biggest
players
Price cuts in several Canadian provinces have further impacted profitability
Automatic substitution is allowed in some provinces/territories
A harmonized policy to promote generic uptake could lead to cost savings
Canada – Key generics players
Apotex faces difficulties in exports to the US
Teva expands operations in Canada
Sandoz
Canada – Opportunities for the generics industry
CANADA – BIOSIMILAR MARKET OVERVIEW
Canada – Roll out of the SEB approval pathway
Key requirements of the Canadian SEB approval pathway
Data exclusivity is 6 years in Canada
Comparison of biosimilars guidelines across major markets
Canada – Drivers of SEB uptake
Omnitrope is approved in Canada
SEB approval may be extrapolated across multiple indications in Canada
Substitution of SEBs discouraged by federal authorities
Canada – Marketed and pipeline SEBs
Omnitrope is the only SEB marketed in Canada
SEBs in development for the Canadian market
Opportunities for the SEB industry
Canada – Key SEB players
Sandoz
Companies looking to enter the Canadian SEB market
BIBLIOGRAPHY
Publications and online articles
Datamonitor reports and products
APPENDIX
Exchange rates used in this report

3. LIST OF TABLES
Table: Canada – key metrics for the Canada Generics & Biosimilars Market, 2011
Table: Canada – comparison of generic penetration versus other major pharmaceutical
markets, 2009–10
Table: Canada – Estimated annual losses attributed to strengthening IP protection
Table: Canada – Generic price cuts, 2010
Table: Canada – Automatic substitution requirements by province/territory, 2009
Table: Canada – sales of leading generics producers, (USD $m) 2009–10
Table: Canada – brands exposed to generic competition, 2011–15
Table: Data exclusivity requirements in Australia, Canada, the EU, US, South Korea, and
Japan, 2011
Table: Canada – Marketed SEBs, 2011
Table: Canadian SEB producers' pipeline activity, 2011
Table: Canada – key biologics expected to come off patent, 2011–15
Table: Sandoz/Hexal’s biosimilar product portfolio, 2011
Table: Currency exchange rates, 2011
LIST OF FIGURES
Figure: Canada – drivers and resistors facing branded pharmaceutical companies
Figure: Canada – comparison of generic volume uptake versus other major pharmaceutical
markets, 2009–10
Figure: Canada – comparison of generic value uptake versus other major pharmaceutical
markets, 2009–10
Figure: Canada – comparison of generics market size in Canada versus other
pharmaceutical markets, 2009–10
Figure: Canada – key factors influencing the generics industry, 2011
Figure: Comparison of biosimilars guidelines across major markets, 2011
Figure: Biosimilars approval pathways
Figure: Canada – key factors influencing the SEB industry, 2011
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