General
- The term "biogeneric" can
simply be defined as a pharmaceutical preparation based on a
biologically active substance. This is in contrast to traditional,
multisource, generic pharmaceuticals.
- A biogeneric is defined as the generic alternative of a
biopharmaceutical or biologic, which is a copy of the original product.
- Apart from the
European and US regulatory developments, first biogeneric R&D activities
are reported in Japan (EPO), but the regulatory situation is not yet
transparent. Biogeneric development activities so far focus on copycats
of first generation protein products, but in the case of hGH slow
release versions of biogeneric hGH are in advanced clinical development
in EU and US territories. Indian companies are already working on
pegylated versions of biogeneric proteins and also started with
development of biogeneric antibodies (rituximab).
Processing
- The major
therapeutic proteins are not only being challenged by biogeneric
developments in the Western countries, but also by innovative
investigational new drugs. A state of the art approach is pegylation
or glycopegylation of the parent protein, but protein engineering
technologies may lead to the same effect of a longer half-life and
also result in improved pharmacodynamic properties.
- The Competitor
Analysis provides a stakeholder evaluation in the US$ 42 bln markets
of 10 major proteins
Market
- The total biopharmaceutical market is valued at US $ 18,000 million with
the US accounting for the largest proportion, 45%, followed by Europe,
30%, Japan, 20%, and the rest of the world, 5%. Assuming a similar
penetration rate for biogenerics as for traditional drugs , then the
potential market for biogenerics would be estimated at US$ 2,000
million.
- Globally, the generic pharmaceutical business generated approximately
$33 billion in revenue in 2002 . The financial success of the generic
pharmaceutical industry has led many industry thought leaders and
company executives to consider developing and manufacturing generic
versions of blockbuster biopharmaceuticals near patent expiry such as
Epogen (erythropoietin-alpha, EPO),Neupogen, (granulocyte colony stimulating factor, G-CSF), and Avonex
(interferon-beta).
- At present, India is one of the major contributors in the world
biogeneric market along with China. The entry of Indian firms, with
their own brands of recombinant products, has changed the dynamics of
the domestic biogenerics market.
- With low capital and operational cost in the area of bio-manufacturing,
industry estimates that the market for biogenerics in India is expected
to see a 43 percent jump from Rs 308.50 crore in 2001 to Rs 1,305.7
crore in 2005 and projected to reach Rs 1,864.3 crore by 2007
registering a growth of 19 percent.
- The main players in Biogenerics market are Sandoz, Cangene, LG
Chemicals, Rhein Biotech, PCGen, Wockhardt, Microbix, GeneMedix, Stada,
DSM Biologicals, and Amgen.
Policies &
Report
- Some policies focused
on subsidising research and development and not on making the types of
structural and regulatory
changes that would support the sustainability of a sustainable
Australian generic pharmaceutical industry linked by incentives to nano/biotechology
companies and increased science education infrastructure.
- The report will
inform the reader about the key obstacles that stand in the way of a
smooth transition from biopharmaceutical manufacture to biogenerics. The
most complex stumbling block is the availability of bulk active
biopharmaceuticals through non-patent-infringing routes. Biogenerics
makers will be particularly challenged by patent
coverage for biopharmaceuticals and also affordable demonstration of
bioequivalence, both of which have been obstacles
to market development.
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