Development of biogeneric molecules for sale in
the potentially highly lucrative US and Western
European markets depends on the ability to
answer three key questions positively:
Can you make the product consistently to GMP and
demonstrate its essential similarity 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 of your biogeneric
product?
This report focuses on the specific strategies
adopted by companies involved in the biogenerics
arena, asking:
- Why are specific strategies likely to be
effective?
- Why are particular companies more likely to be
successful in the race to enter and profit from
the biogenerics market in Europe and the US?
Biogenerics companies tend to adopt four main
approaches. Often any one company will take more
than one approach:
- Focus on strategic partnerships.
- Expand through acquisition.
- Supply into developing markets initially,
followed by Europe and eventually the US.
- Develop second-generation products.
The earliest that biogenerics are likely to come
to market is 2006, for the simpler products,
such as G-CSF, rh GM-CSF and first-generation rh
EPOs. However there is significant potential for
delay along the route from:
- Regulators wrestling with the application of
new rules. An example of this is Omnitrop
(recombinant human growth hormone), which the
Committee for Proprietary Medicinal Products (CPMP),
the scientific committee of the European Agency
for the Evaluation of Medicinal Products (EMEA),
recommended for approval in Europe in June 2003.
Omnitrop was ultimately rejected by the European
Commission in April 2004.
- Innovators employing delaying tactics aimed at
preventing biogenerics from taking shorter
routes to approval.
- Development of second-generation products that
are significantly better than the originals,
meaning that original products are unlikely to
take significant market share.
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