Introduction With several blockbuster biological products approaching patent expiry, the biogenerics segment represents an attractive opportunity for companies looking to escape intensifying competition in the commodity generics sector. The generics industry is pushing for establishment of an approval pathway for generic biologics, but even once this is in place, barriers to market entry will be high. Scope - Evaluation of developments in the regulatory environment for biogenerics in the US and EU
- Analysis of market entry strategies of likely key biogenerics players
- Assessment of the market potential of biogenerics, and the barriers to companies wishing to exploit this
Highlights While the US represents the major market for regular generics, in the case of biogenerics, Europe is leading the development of the Western market, with the issue having been addressed as part of a restructuring of pharmaceutical legislation, making Europe the first market to establish a legal framework for authorization of biogenerics. Despite the high potential, relatively few companies are expected to enter Western biogenerics markets due to high barriers to entry. Companies may try to overcome these barriers by entering the superbiogenerics market, where higher returns are achievable. Players in the biogenerics market fall into two key categories: biotech start-ups such as Cangene, Microbix and GeneMedix, and established generics companies looking to expand their existing portfolios such as Stada, Teva, and Sandoz. Reasons to Purchase - Evaluate the strategies of key biogenerics contenders, and assess their threat to your business
- Understand the key regulatory issues surrounding approval of biogenerics
- Assess the barriers to entry in the biogenerics sector, as well as the market potential
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