Generic Drug in Canada: Canada: Generics and Biosimilars Overview

• Publication date: November 2011

About This Report The Canadian generic drugs industry faces a number of challenges, although provinces are now implementing strategies to increase competition in the industry, and provide greater opportunities for smaller generic drugs 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. What's Included i...

About This Report

The Canadian generic drugs industry faces a number of challenges, although provinces are now implementing strategies to increase competition in the industry, and provide greater opportunities for smaller generic drugs 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.

What's Included in This Report?


* Compares the Canadian generic drugs industry in terms of value and volume to other leading developed and emerging industries.

* Insight into the key drivers and resistors to generic drugs 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.

Key Market Facts

The Canadian generic drugs industry is facing a number of challenges with strengthening intellectual property laws threatening to delay industry 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 industry, and provide greater opportunities for smaller generic drugs players. Furthermore, harmonization of provincial generic regulations would improve generic uptake and reduce bureaucracy and confusion for generic drugs firms .
While the SEB industry 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 industry in the near future.

Why Should You Buy This Report?


* Evaluate the evolving regulatory environments for generic drugs and biosimilars/SEBs in Canada, and how this impacts industry access and uptake.

* Identify the key companies and future biosimilar/SEB and generic opportunities in Canada.

Generic Drug Industry in Canada

Summary
Introduction
Canada – Strategic scoping and focus
Canada – Datamonitor key findings
Generic Drugs industry
Biosimilars industry
Related reports
CANADA – GENERICS MARKET OVERVIEW
Canada – Generic Drugs industry dynamics
Canada generics drugs volume uptake
Canada generics drugs value uptake
Canada generics drugs industry size
Canada – Generic Drugs drivers and resistors
Strengthening IP laws could cost Canada USD 2.8bn in lost savings
Generic exports to emerging industry s set to increase
Pharmacist rebate agreements lead to high generics drugs 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 drugs players
Apotex faces difficulties in exports to the US
Teva grow s operations in Canada
Sandoz
Canada – Opportunities for the generics drugs market
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 industry s
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 – Industry ed and pipeline SEBs
Omnitrope is the only SEB industry ed in Canada
SEBs in development for the Canadian industry
Opportunities for the SEB market
Canada – Key SEB players
Sandoz
Firms looking to enter the Canadian SEB industry
BIBLIOGRAPHY
Publications and online articles
Datamonitor reports and products
APPENDIX
Exchange rates used in this report

Generic Drug in Canada

Canada Generic Drug Sales, Us$bn, % Chg Y-o-y

• $ 250
• Industry data
• January 2013

Yearly, From 2006 To 2021
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn

• $ 250
• Industry data
• January 2013

Yearly, From 2005 To 2021
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn, 5 Year Trailing Cagr, %

• $ 250
• Industry data
• January 2013

Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn, 5 Year Forward Cagr, %

• $ 250
• Industry data
• January 2013

Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada

Canada Generic Drug Sales, Us$bn, 10 Year Forward Cagr, %

• $ 250
• Industry data
• January 2013

Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: Canadian Generic Pharmaceutical Association (CGPA), Patented Medicine Prices Review Board (PMPRB), B

• Industries : Generic Drug
• Countries : Canada