Description
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.
Your key questions answered
- Evaluate the evolving regulatory environments for generics and biosimilars/SEBs in Canada, and how this impacts market access and uptake.
- Identify the leading players and future biosimilar/SEB and generic opportunities in Canada.
TOC
Executive Summary
- Introduction
- Canada - Strategic scoping and focus
- Canada - Datamonitor key findings
- Generics market
- 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
