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.
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