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Biogenerics: Drivers and Resistors of Market Development


Description: 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 of this report: - 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. Report 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. “...If you are trying to play the game we have all tried before -to all work from the same list for 90% of those products, the Indians will be able to do it cheaper and quicker. Companies will need to move to value added, barrier to entry products to survive...” Generics Company Executive Reasons to Purchase 1. Evaluate the strategies of key biogenerics contenders, and assess their threat to your business 2. Understand the key regulatory issues surrounding approval of biogenerics 3. Assess the barriers to entry in the biogenerics sector, as well as the market potential “...You have to look at value added products, even in generics… where there is the opportunity for value added products, derived from the greater complexity in development and approval, the margins are greater...” Generics Company Executive


Contents: CHAPTER 1 KEY FINDINGS CHAPTER 2 THE REGULATORY ENVIRONMENT FOR BIOGENERICS Moving toward a regulatory pathway for biogenerics “Bioequivalence vs. product comparability” and “process makes the product” Growing demand for biogenerics US – does the FDA have the right to apply 505(b)(2)? Europe – is the EMEA a step ahead? Rest of World – an attractive launchpad? Implications for biogenerics manufacturers CHAPTER 3 BIOGENERICS MARKET POTENTIAL Biogenerics : risk versus return Drivers of biogenerics market development Resistors to biogenerics market development Superbiogenerics CHAPTER 4 KEY CONTENDERS Key characteristics for a well positioned biogenerics company LIST OF TABLES Table 1: Key biological product patent expiries Table 2: Product classes in the pipelines of 14 biogenerics companies Table 3: Sales of SICOR’s biogenerics portfolio, 2001–02 Table 4: SICOR’s biogenerics pipeline, 2003 Table 5: Stada’s biogenerics pipeline, 2003 LIST OF FIGURES Figure 1: Analysis of classes most at risk from biogeneric competition Figure 2: Biogenerics capabilities of selected companies Figure 3: Alliances of selected biogenerics players Figure 4: BioGeneriX’s partnering strategy




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