What will determine success?
Development of biogeneric molecules for sale in the potentially highly lucrativeUS and Western European markets depends on the ability to answer three keyquestions positively:
Can you make the product consistently to GMP and demonstrate its essentialsimilarity to originator products?
- Having made the product, can you get it to market?
- Having accessed the market, are you able to make a profit from the sales ofyour biogeneric product?
This report focuses on the specific strategies adopted by companies involved inthe biogenerics arena, asking:
- Why are specific strategies likely to be effective?
- Why are particular companies more likely to be successful in the race to enterand profit from the biogenerics market in Europe and the US?
Biogenerics companies tend to adopt four main approaches. Often any onecompany will take more than one approach:
- Focus on strategic partnerships.
- Expand through acquisition.
- Supply into developing markets initially, followed by Europe and eventuallythe US.
- Develop second-generation products.
The earliest that biogenerics are likely to come to market is 2006, for thesimpler products, such as G-CSF, rh GM-CSF and first-generation rh EPOs. Howeverthere is significant potential for delay along the route from:
- Regulators wrestling with the application of new rules. An example of this isOmnitrop ( recombinant human growth hormone ), which the Committee forProprietary Medicinal Products ( CPMP ), the scientific committee of theEuropean Agency for the Evaluation of Medicinal Products ( EMEA ), recommendedfor approval in Europe in June 2003. Omnitrop was ultimately rejected by theEuropean Commission in April 2004.
- Innovators employing delaying tactics aimed at preventing biogenerics fromtaking shorter routes to approval.
- Development of second-generation products that are significantly better thanthe originals, meaning that original products are unlikely to take significantmarket share.
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